| Primary | Coprimary Endpoint: Change From Baseline in Inferior Corneal Fluorescein Staining Score to Day 57 (Pre- to Post-CAE) | It was evaluated for the inferior region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | ITT Population with the Markov Chain Monte Carlo (MCMC) imputation method for missing values. | Posted | | Mean | Standard Deviation | score on a scale | | Pre-CAE and Post-CAE on Day 1 (Baseline) and Day 57 | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants sefl-administered HL036 placebo matching vehicle solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57. |
| | | Title | Denominators | Categories |
|---|
| Day 1 (Change from Pre-CAE to Post-CAE) | | | Title | Measurements |
|---|
| - OG0001.38± 0.427
- OG0011.31± 0.411
|
| | Change from baseline: Day 57 (Change from Pre-CAE to Post-CAE) | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | 0.1871 | P-value calculated using a model with treatment, baseline score, and site as covariates. | Least Squares (LS) Mean Difference | 0.08 | Standard Error of the Mean | 0.064 | 2-Sided | 95 | -0.04 | 0.21 | | | | | Superiority | | |
|
| Primary | Coprimary Endpoint: Change From Baseline in Ocular Discomfort Score to Day 57 (Pre-CAE) | It is assessed by the Ora Calibra® Ocular Discomfort scale. The score ranged from 0 to 4 (0=none and 4=severe) with 1 point increments, where lower scores indicate improvement. | ITT Population with the MCMC imputation method for missing values. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE), Day 57 (Pre-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants sefl-administered HL036 placebo matching vehicle solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Fluorescein Staining (Inferior Region) | It is evaluated for the inferior region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Fluorescein Staining (Superior Region) | It is evaluated for the superior region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Fluorescein Staining (Central Region) | It is evaluated for the central region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Fluorescein Staining (Temporal Region) | It is evaluated for the temporal region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Fluorescein Staining (Nasal Region) | It is evaluated for the nasal region on the Ora Calibra® and Conjunctival staining scale. The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Fluorescein Staining (Corneal Sum) | Corneal sum score is the sum of all regions of the cornea (inferior, superior and central regions). Individual region score was evaluated on the Ora Calibra® and Conjunctival staining scale. Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Corneal sum score ranges from 0 to 12. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Fluorescein Staining (Conjunctival Sum) | Conjunctival sum score is the sum of all regions of the conjunctiva (temporal and nasal regions). Individual region score was evaluated on the Ora Calibra® and Conjunctival staining scale. Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Corneal sum score ranges from 0 to 8. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Fluorescein Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Total score was sum of all 5 regions: central, superior, inferior, temporal, and nasal. Individual region score was evaluated on the Ora Calibra® and Conjunctival staining scale. Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 20. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Lissamine Green Staining Score (Inferior Region) | It is evaluated for the inferior region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Lissamine Green Staining Score (Superior Region) | It is evaluated for the superior region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Lissamine Green Staining Score (Central Region) | It is evaluated for the central region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Lissamine Green Staining Score (Temporal Region) | It is evaluated for the temporal region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Lissamine Green Staining Score (Nasal Region) | It is evaluated for the nasal region on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). The score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Lissamine Green Staining (Corneal Sum) | Corneal sum score is the sum of all regions of the cornea (inferior, superior and central regions). Individual region score was evaluated on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 12. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Lissamine Green Staining (Conjunctival Sum) | Conjunctival sum score is the sum of all regions of the conjunctiva (temporal and nasal regions). Individual region score was evaluated on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 8. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Mean Change From Baseline in Lissamine Green Staining Total Score (All Five Regions: Central, Superior, Inferior, Temporal, Nasal) | Total score was sum of all 5 regions: central, superior, inferior, temporal, and nasal. Individual region score was evaluated on the lissamine green corneal and conjunctival staining scale (Ora Calibra® scale). Individual region score ranges from 0 to 4 (0=none and 4=severe), and lower score indicates improvement. Total score ranges from 0 to 20. Change score from pre- to post-CAE® was calculated as post-CAE® score - pre-CAE® score. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Measure Title Change From Baseline in the Ora Calibra® Conjunctival Redness Scale | It is evaluated by the Ora Calibra® conjunctival redness scale for dry eye. The score ranges from 0 to 4 (0=none and 4=severe), where lower score indicates improvement | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Change From Baseline in Schirmer's Test | The Schirmer test strip will be placed in the lower temporal lid margin of each eye. Participants will be instructed to close their eyes and After 5 minutes have elapsed, The length of moistened area of schirmer strip will be recorded (mm) for each eye. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Post CAE on baseline (Day 1) and Days 15, 29, and 57 | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Change From Baseline in Tear Film Break-Up Time | Sodium fluorescein solution was instilled into each eye and participants were instructed to blinked several times. The time it takes to form micelles from the time that the eye is opened was noted. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | seconds | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Change From Baseline in Ocular Surface Disease Index (OSDI) | The OSDI is a simple 12-question survey that rates the severity of the participant's dry eye disease based on the symptoms. It is assessed on a scale of 0 to 100, with higher score representing greater disability. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Pre-CAE on baseline (Day 1) and Days 15, 29, and 57; Day 8 | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Change From Baseline in Visual Analog Scale (Blurry Vision) | Participants rated ocular symptom of blurry vision by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort." | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
| |
| Secondary | Change From Baseline in Visual Analog Scale (Burning/Stinging) | Participants rated ocular symptom of burning/stinging by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort." | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Change From Baseline in Visual Analog Scale (Itching) | Participants rated ocular symptom of itching by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort." | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Change From Baseline in Visual Analog Scale (Foreign Body Sensation) | Participants rated ocular symptom of foreign body sensation by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort." | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Change From Baseline in Visual Analog Scale (Eye Dryness) | Participants rated ocular symptom of eye dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort." | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Change From Baseline in Visual Analog Scale (Photophobia) | Participants rated ocular symptom of photophobia by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort." | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Change From Baseline in Visual Analog Scale (Pain) | Participants rated ocular symptom of pain by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0 mm corresponds to "no discomfort" and 100 mm corresponds to "maximal discomfort." | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Change From Baseline in Ocular Discomfort Scale | It was assessed by the Ora Calibra® ocular discomfort scale. The score ranges from 0 to 4 (0=none and 4=severe), where lower score indicates improvement. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. At each day during the at-home dosing period, subjects will grade the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of overall ocular discomfort on 0 to 5 scale, where 0=none and 5=severe. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of burning on 0 to 5 scale, where 0=none and 5=severe. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of dryness on 0 to 5 scale, where 0=none and 5=severe. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of grittiness on 0 to 5 scale, where 0=none and 5=severe. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. At each day during the at-home dosing period, subjects graded the severity of their dry eye syndrome symptoms in the morning and in the evening, before instilling the study drug. Participants rated the severity of stinging on 0 to 5 scale, where 0=none and 5=severe. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | mm | | Baseline (Day 1 Pre-CAE and Post-CAE), Day 8, Day 15 (Pre-CAE and Post-CAE), Day 29 (Pre-CAE and Post-CAE), and Day 57 (Pre-CAE and Post-CAE) | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Ora Calibra® Drop Comfort Scale | Ora Calibra® drop comfort scale ranges from 0 to 10. A score of 0 indicates comfortable and 10 indicates uncomfortable. Lower score indicated better comfort level. | The ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | Upon instillation and 1 and 2 minutes post-instillation on Day 1 | | | | ID | Title | Description |
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| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 percent (%) ophthalmic solution as topical ophthalmic drops, twice daily (BID) for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants sefl-administered HL036 placebo matching vehicle solution as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the controlled adverse environment® (CAE) were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Overall Ocular Discomfort) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of overall ocular discomfort twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | From Day -14 to Day 56 | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Burning) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of burning twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | From Day -14 to Day 56 | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Dryness) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of dryness twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | From Day -14 to Day 56 | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Grittiness) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of grittiness twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | From Day -14 to Day 56 | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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| Secondary | Daily Diary: Change From Baseline in Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire for Dry Eye (Stinging) | Ora Calibra® ocular discomfort & 4-symptom questionnaire for dry eye includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Participants rated the severity of stinging twice a day in a diary on 0 to 5 scale, where 0=none and 5=severe. Higher score represent higher severity. The average of the morning and evening assessments were calculated for each day. Weekly average scores were calculated based on the daily scores in the week. | Number of participants analyzed included participants in ITT Population with available data. The analysis was carried out with observed data only. | Posted | | Mean | Standard Deviation | score on a scale | | From Day -14 to Day 56 | | | | ID | Title | Description |
|---|
| OG000 | 0.25% HL036 Ophthalmic Solution | Participants self-administered HL036 0.25 % ophthalmic solution as topical ophthalmic drops BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. | | OG001 | Placebo | Participants self-administered HL036 placebo (vehicle solution) as topical ophthalmic drops, BID for up to 8 weeks. Exposures to the CAE® were conducted at Day 1, Day 15, Day 29 and Day 57. |
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