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Unexpected adverse events were observed in a subset of patients on drug. In an over abundance of caution the study was terminated. All adverse events resolved with no sequelae.
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This study will evaluate the safety, tolerability and efficacy of IC265 compared to vehicle in participants with signs and symptoms dry eye disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC265 Ophthalmic Solution 1% | Experimental | 1 drop will be instilled in each eye twice daily. |
|
| Placebo Ophthalmic Solution (Vehicle) | Placebo Comparator | 1 drop will be instilled in each eye twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IC265 Ophthalmic Solution 1% | Drug | 1 drop will be instilled in each eye twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Discomfort and Dry Eye Symptoms | Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst. | Change from Baseline Post-CAE® (controlled adverse environment) Day 15 |
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| Measure | Description | Time Frame |
|---|---|---|
| Tear Film Break-up Time (TFBUT) | With the aid of a slit-lamp, the examiner will monitor the integrity of the tear film, noting the time it takes to form micelles from the time that the eye is opened. TFBUT will be measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. For each eye, 2 measurements will be taken and averaged unless the 2 measurements are > 2 seconds apart and are each < 10 seconds, in which case, a third measurement would be taken and the 2 closest of the 3 would be averaged. |
Inclusion Criteria:
Be at least 18 years of age;
Provide written informed consent
Have a reported or documented history of dry eye for at least 6 months prior to Visit 1
Have a history of use or desire to use eye drops for dry eye symptoms within 6 months of Visit 1
Report a score of ≥ 2 on a Ocular Discomfort & 4-symptom questionnaire in at least one symptom at Visits 1 and 2
Have a Schirmer's Test score of ≤10mm and ≥1mm in at least one eye at Visits 1and 2
Have a pre-CAE(controlled adverse environment) (conjunctival redness score ≥ 1 according to the Conjunctival Redness for Dry Eye Scale in at least one eye at Visits 1 and 2
Have a corneal fluorescein staining score of ≥ 2 in at least one region (e.g. inferior, superior, or central) at Visits 1 and 2
Have a sum corneal fluorescein staining score of ≥ 4, based on the sum of the inferior, superior, and central regions at Visits 1 and 2
Have a total lissamine green conjunctival score of ≥ 2, based on the sum of the temporal and nasal regions at Visits 1 and 2
Demonstrate a response to the CAE at Visits 1 and 2 as defined by:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iacta Selected Site | Andover | Massachusetts | 01810 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | IC265 Ophthalmic Solution 1% | 1 drop will be instilled in each eye twice daily. IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day |
| FG001 | Placebo Ophthalmic Solution (Vehicle) | 1 drop will be instilled in each eye twice daily. Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IC265 Ophthalmic Solution 1% | 1 drop will be instilled in each eye twice daily. IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day |
| BG001 | Placebo Ophthalmic Solution (Vehicle) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ocular Discomfort and Dry Eye Symptoms | Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst. | Intent to Treat - only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline Post-CAE® (controlled adverse environment) Day 15 | eyes | eyes |
|
The adverse events were collected over the duration of the trial out to Visit 3, Day 15. The study was terminated early and patients were discontinued from study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IC265 Ophthalmic Solution 1% | 1 drop will be instilled in each eye twice daily. IC265 Ophthalmic Solution 1%: 1 drop will be instilled in each eye twice a day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Corneal neovascularisation | Eye disorders | Non-systematic Assessment |
The study was terminated early, Visit 3 Day 15, due to the unexpected epithelial haze findings in several subjects on IC265. All but one AEs of epithelial haze observed in several of subjects in IC265 OS 1% were mild and resolved without intervention in all cases. The study was discontinued in the abundance of caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Operating Officer | Iacta Pharmaceuticals | 714-330-8532 | sj@iactapharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 12, 2023 | Dec 23, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2023 | Dec 23, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Placebo Ophthalmic Solution (Vehicle) | Drug | 1 drop will be instilled in each eye twice a day |
|
| Change from Baseline Pre-CAE® (controlled adverse environment) in TFBUT in Study Eye Day 15 |
| Ocular Surface Disease Index (OSDI)© | Change from baseline to Visit 3 (Day 15). Subjects will complete the OSDI© questionnaire. The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. the OSDI© is a valid and reliable instrument for measure dry eye disease (normal, mild to moderate, and severe) and effects vision-related function. | Day 15 |
| Schirmer's Test | Change from Baseline. Schirmer Tear Test will be performed according to the following procedure:
| Day 15 |
| Ocular Discomfort During CAE - Change From Baseline to Visit 3 | Change from Baseline in Ora to Visit 3 Calibra® Ocular Discomfort Scale During the CAE® in the Study Eye. Ocular discomfort scores will be subjectively graded by the subjects according to the following scale: 0 - no discomfort, 1 - intermittent awareness, 2 - constant awareness, 3 - intermittent discomfort, 4 - constant discomfort. | Day 15 |
| Daily Diary Symptom Score | Subject Daily Diary in the Evening - Day 8 to Day 14 average, Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.The average of the daily diary scores will be summarized using continuous descriptive statistics for the time period. | Daily Diary Evening - Day 8 to Day 14 |
| Conjunctival Redness | Conjunctival Redness 5 point scale (0 - Normal, without vasodilation, 1 - Trace ciliary or conjunctival vasodilation, 2 - Broad ciliary vasodilation, 3 - Broad ciliary and slight, horizontal conjunctival vasodilation, 4 - Broad ciliary and prominent, horizontal conjunctival vasodilation) | Change from Baseline to Day 15 |
| Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Change from Baseline Pre-CAE® in Corneal Lissamine Green Staining in Study Eye. The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent). | Day 15 |
| Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Change from Baseline Pre-CAE® to Post-CAE® in Corneal Fluorescein Staining in the Study Eye. The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent). | Day 15 |
1 drop will be instilled in each eye twice daily.
Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Placebo Ophthalmic Solution (Vehicle) |
1 drop will be instilled in each eye twice daily. Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day |
|
|
| Other Pre-specified | Tear Film Break-up Time (TFBUT) | With the aid of a slit-lamp, the examiner will monitor the integrity of the tear film, noting the time it takes to form micelles from the time that the eye is opened. TFBUT will be measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. For each eye, 2 measurements will be taken and averaged unless the 2 measurements are > 2 seconds apart and are each < 10 seconds, in which case, a third measurement would be taken and the 2 closest of the 3 would be averaged. | Change from Baseline Pre-CAE® in TFBUT in Study Eye - Intent-to-Treat Population. Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15. | Posted | Mean | Standard Deviation | seconds | Change from Baseline Pre-CAE® (controlled adverse environment) in TFBUT in Study Eye Day 15 | eyes | eyes |
|
|
|
| Other Pre-specified | Ocular Surface Disease Index (OSDI)© | Change from baseline to Visit 3 (Day 15). Subjects will complete the OSDI© questionnaire. The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. the OSDI© is a valid and reliable instrument for measure dry eye disease (normal, mild to moderate, and severe) and effects vision-related function. | Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15. | Posted | Mean | Standard Deviation | score on a scale | Day 15 | eyes | eyes |
|
|
|
| Other Pre-specified | Schirmer's Test | Change from Baseline. Schirmer Tear Test will be performed according to the following procedure:
| Posted | Mean | Standard Deviation | mm | Day 15 | eyes | eyes |
|
|
|
| Other Pre-specified | Ocular Discomfort During CAE - Change From Baseline to Visit 3 | Change from Baseline in Ora to Visit 3 Calibra® Ocular Discomfort Scale During the CAE® in the Study Eye. Ocular discomfort scores will be subjectively graded by the subjects according to the following scale: 0 - no discomfort, 1 - intermittent awareness, 2 - constant awareness, 3 - intermittent discomfort, 4 - constant discomfort. | Intent to Treat - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution reached Day 15. | Posted | Mean | Standard Deviation | score on a scale | Day 15 | eyes | eyes |
|
|
|
| Other Pre-specified | Daily Diary Symptom Score | Subject Daily Diary in the Evening - Day 8 to Day 14 average, Subjects will rate the severity of each of the following symptoms, with regard to how both their eyes feel, in general - overall ocular discomfort, burning, dryness, grittiness and stinging according to the following 6-point (0 to 5) scale where 0 = none and 5 = worst.The average of the daily diary scores will be summarized using continuous descriptive statistics for the time period. | Intent to Treat - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution provided daily diaries in this timeframe. | Posted | Mean | Standard Deviation | score on a scale | Daily Diary Evening - Day 8 to Day 14 |
|
|
|
| Other Pre-specified | Conjunctival Redness | Conjunctival Redness 5 point scale (0 - Normal, without vasodilation, 1 - Trace ciliary or conjunctival vasodilation, 2 - Broad ciliary vasodilation, 3 - Broad ciliary and slight, horizontal conjunctival vasodilation, 4 - Broad ciliary and prominent, horizontal conjunctival vasodilation) | Intent to Treat - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution provided daily diaries in this timeframe. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Day 15 | eyes | eyes |
|
|
|
| Other Pre-specified | Lissamine Green Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Change from Baseline Pre-CAE® in Corneal Lissamine Green Staining in Study Eye. The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent). | Intent-to-Treat Population - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution provided daily diaries in this timeframe. | Posted | Mean | Standard Deviation | score on a scale | Day 15 | eyes | eyes |
|
|
|
| Other Pre-specified | Fluorescein Staining in the Following Regions: Central, Superior, Inferior, Temporal, Nasal, Corneal Sum, Conjunctival Sum, and Total Eye Score | Change from Baseline Pre-CAE® to Post-CAE® in Corneal Fluorescein Staining in the Study Eye. The staining will be graded with a Corneal and Conjunctival Staining Scale. The scale is a 5 point scale from 0 (no staining) to 4 (confluent). | Intent-to-Treat Population - Only 14 participants in the IC265 Ophthalmic Solution 1% and 19 in the Placebo Ophthalmic Solution provided daily diaries in this timeframe. | Posted | Mean | Standard Deviation | score on a scale | Day 15 | eyes | eyes |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| 20 |
| 20 |
| EG001 | Placebo Ophthalmic Solution (Vehicle) | 1 drop will be instilled in each eye twice daily. Placebo Ophthalmic Solution (Vehicle): 1 drop will be instilled in each eye twice a day | 0 | 20 | 0 | 20 | 5 | 20 |
| Corneal Opacity | Eye disorders | Non-systematic Assessment |
|
| Eye Pruritus | Eye disorders | Non-systematic Assessment |
|
| Instillation site foreign body sensation | Eye disorders | Non-systematic Assessment |
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| Instillation site irritation | Eye disorders | Non-systematic Assessment |
|
| Lacrimation Increased | Eye disorders | Non-systematic Assessment |
|
| Vision Blurred | Eye disorders | Non-systematic Assessment |
|
| Visual Acuity reduced | Eye disorders | Non-systematic Assessment |
|
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| 10 Minutes |
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| 15 Minutes |
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| 20 Minutes |
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| 25 Minutes |
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| 30 Minutes |
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| 35 Minutes |
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| 40 Minutes |
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| 45 Minutes |
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| 50 Minutes |
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| 55 Minutes |
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| 60 Minutes |
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| 65 Minutes |
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| 70 Minutes |
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| 75 Minutes |
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| 80 Minutes |
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| 85 Minutes |
|
| 90 Minutes |
|
| Dryness |
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| Grittiness |
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| Stinging |
|
| Central |
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| Temporal |
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| Nasal |
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| Corneal Sum |
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| Conjunctival Sum |
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| Total Sum |
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| Central |
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| Temporal |
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| Nasal |
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| Corneal Sum |
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| Conjunctival Sum |
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| Total Sum |
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