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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
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The objective of this study is to compare the safety and efficacy of two different concentrations of ST-100 Ophthalmic Solution to placebo (vehicle) for the treatment of the signs and symptoms of dry eye.
This is a Phase 2, multi-center, double-masked, randomized, placebo-controlled clinical study. Subjects will be randomized to one of the following treatment arms at Visit 2 (Day 1):
Approximately 150 subjects will be randomly assigned to one of the three groups (1:1:1) to receive either ST-100 Ophthalmic Solution or placebo solution as topical ophthalmic drops administered bilaterally BID for 4 weeks. Subjects, Sponsor, Contract Research Organization (CRO), and site personnel will be masked to treatment assignment.
The clinical hypotheses for this study is that low dose and high dose ST-100 Ophthalmic Solution twice daily (BID) is superior to its vehicle (BID) for the primary endpoints of signs and symptoms of dry eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Active Comparator | Low Dose ST100-001 Ophthalmic solution, 20mcg/ml |
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| High Dose ST-100 Ophthalmic Solution | Active Comparator | High Dose ST100-001 Ophthalmic Solution, 50mcg/ml |
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| Placebo Ophthalmic Solution | Placebo Comparator | Placebo Ophthalmic Solution (vehicle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ST-100 Ophthalmic Solution | Drug | One drop in each eye twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline of Total Corneal Fluorescein Staining (Ora Calibra® Scale) in the Study Eye at Visit 7 (Day 29) Pre-Controlled Adverse Environment (Pre-CAE) | The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate 3 corneal regions. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The scoring reported ranges from 0-12. Mean change from baseline was calculated. | Visit 2 (Day 1) to Visit 7 (Day 29) |
| Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE | Ocular Discomfort Scale is graded using the Ora Calibra Ocular Discomfort Scale (ODS). The scale ranges from 0 means no discomfort to 4 means worst discomfort. Higher score indicates more discomfort. | Visit 2 (Day 1) to Visit 7 (Day 29) |
| Measure | Description | Time Frame |
|---|---|---|
| Unanesthetized Schirmer's Responder Rate | The Schirmer's test strip is placed in the lower temporal lid margin of each eye. After 5 minutes, the test strip is removed and the length of the moistened area will be recorded in millimeters (mm) for each eye. The percentage of responders who had ≥ 10 mm increase from baseline in study eye in unanesthetized Schirmer's test was recorded. | Visit 7 (Day 29), Pre-CAE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert O Baratta, MD | Stuart Therapeutics, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andover Eye Associates | Andover | Massachusetts | 01810 | United States | ||
| Andover Eye Associates - Raynham |
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All participants participated in the run-in phase of the study before randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Low Dose ST-100 Ophthalmic Solution | Low Dose ST100-001 Ophthalmic solution, 20mcg/ml ST-100 Ophthalmic Solution: One drop in each eye twice a day |
| FG001 | High Dose ST-100 Ophthalmic Solution | High Dose ST100-001 Ophthalmic Solution, 50mcg/ml ST-100 Ophthalmic Solution: One drop in each eye twice a day |
| FG002 | Placebo Ophthalmic Solution | Placebo Ophthalmic Solution (vehicle) Placebo Ophthalmic Solution: One drop in each eye twice a day |
| FG003 | Run-In | Run-In Phase |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo Run-In |
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| Randomized Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Low Dose ST-100 Ophthalmic Solution | Low Dose ST100-001 Ophthalmic solution, 20mg/ml ST-100 Ophthalmic Solution: One drop in each eye twice a day |
| BG001 | High Dose ST-100 Ophthalmic Solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change From Baseline of Total Corneal Fluorescein Staining (Ora Calibra® Scale) in the Study Eye at Visit 7 (Day 29) Pre-Controlled Adverse Environment (Pre-CAE) | The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate 3 corneal regions. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The scoring reported ranges from 0-12. Mean change from baseline was calculated. | Posted | Least Squares Mean | Standard Error | units on a scale | Visit 2 (Day 1) to Visit 7 (Day 29) | Study Eye | Study Eye |
|
Through study completion, an average of 1 month
Safety population: 52 in low dose, 53 in high dose, 54 in Placebo. ST-100 was safe and well tolerated in the study. There were no meaningful imbalances among treatment groups in either ocular or non-ocular treatment emergent adverse events. All serious adverse events were considered unexpected and not related to study drug. Other AEs > 5% (reduced VA and instillation site pain) were seen in one or at most two early visits but were no longer seen in the same patients as the trial progressed.
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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 | Low Dose ST-100 Ophthalmic Solution | Low Dose ST100-001 Ophthalmic solution, 20mg/ml ST-100 Ophthalmic Solution: One drop in each eye twice a day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory Depression related to congestive heart failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual acuity reduced | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Del Buono, Executive Vice President | Stuart Therapeutics | 7034025866 | brian@stuarttherapeutics.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 | May 21, 2021 | May 1, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 25, 2021 | May 1, 2023 | 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 | Drug | One drop in each eye twice a day |
|
|
| Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2) | LogMAR visual acuity (VA) is assessed using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The last line in which a letter is read correctly will be taken as the base logMAR reading. To this value will be added the number "N x 0.02" where 'N' represents the total number of letters missed up to and included in the last line read. This total sum represents the logMAR VA for that eye. | Visit 3 (Day 2) |
| Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision) | Ocular Surface Disease Index (OSDI) Questions 4: Have you experienced blurred vision during the last week? on 0-4 Scale where 4 is the worst at pre-CAE® | Visit 4 (Day 4), Non-CAE |
| Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain) | Ocular Surface Disease Index (OSDI) Questions 3: Have you experienced painful or sore eyes during the last week? on 0-4 Scale where 4 is the worst at pre-CAE® | Visit 6 (Day 15) Pre-CAE |
| Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire | The Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire is used, which includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Each symptom rating ranges from 0 to 5, where 0 = None and 5 = Worst. Higher score means worse symptom. Min score = 0, max score = 25. | Visit 6 (Day 15) Pre-CAE |
| Raynham |
| Massachusetts |
| 02767 |
| United States |
| Total Eye Care, P.A. | Memphis | Tennessee | 38119 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
ST-100 Ophthalmic Solution: One drop in each eye twice a day
| BG002 | Placebo Ophthalmic Solution | Placebo Ophthalmic Solution (vehicle) Placebo Ophthalmic Solution: One drop in each eye twice a day |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Total Corneal Fluorescein Staining | The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate inferior, superior, central, temporal, and nasal region. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The corneal sum score is the sum from the inferior, superior, and central regions (min 0, max 12). The conjunctival sum score is the sum of scores from the nasal and temporal regions (min 0, max 8). The total eye score is the sum of scores from all five regions (min 0, max 20). | Mean | Standard Deviation | units on a scale |
|
| Ocular Discomfort Scale | Ocular Discomfort Scale is graded using the Ora Calibra Ocular Discomfort Scale (ODS). The scale ranges from 0 means no discomfort to 4 means worst discomfort. Higher score indicates more discomfort. | Mean | Standard Deviation | units on a scale |
|
| Unanesthetized Schirmer's test | Mean | Standard Deviation | mm |
|
| High Dose ST-100 Ophthalmic Solution |
High Dose ST100-001 Ophthalmic Solution, 50mg/ml ST-100 Ophthalmic Solution: One drop in each eye twice a day |
| OG002 | Placebo Ophthalmic Solution | Placebo Ophthalmic Solution (vehicle) Placebo Ophthalmic Solution: One drop in each eye twice a day |
|
|
|
| Primary | Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE | Ocular Discomfort Scale is graded using the Ora Calibra Ocular Discomfort Scale (ODS). The scale ranges from 0 means no discomfort to 4 means worst discomfort. Higher score indicates more discomfort. | Posted | Least Squares Mean | Standard Error | score on a scale | Visit 2 (Day 1) to Visit 7 (Day 29) | Study Eye | Study Eye |
|
|
|
|
| Secondary | Unanesthetized Schirmer's Responder Rate | The Schirmer's test strip is placed in the lower temporal lid margin of each eye. After 5 minutes, the test strip is removed and the length of the moistened area will be recorded in millimeters (mm) for each eye. The percentage of responders who had ≥ 10 mm increase from baseline in study eye in unanesthetized Schirmer's test was recorded. | The measurements are reported for each visit. The number of subjects in each group varied at each visit. The overall analyzed number of participants are from the ITT population. | Posted | Count of Participants | Participants | Visit 7 (Day 29), Pre-CAE |
|
|
|
|
| Secondary | Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2) | LogMAR visual acuity (VA) is assessed using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The last line in which a letter is read correctly will be taken as the base logMAR reading. To this value will be added the number "N x 0.02" where 'N' represents the total number of letters missed up to and included in the last line read. This total sum represents the logMAR VA for that eye. | The measurements are reported for each visit. The number of subjects in each group varied at each visit. The overall analyzed number of participants are from the ITT population. | Posted | Least Squares Mean | Standard Error | logMAR | Visit 3 (Day 2) | Fellow Eye | Fellow Eye |
|
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| Secondary | Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision) | Ocular Surface Disease Index (OSDI) Questions 4: Have you experienced blurred vision during the last week? on 0-4 Scale where 4 is the worst at pre-CAE® | The measurements are reported for each visit. The number of subjects in each group varied at each visit. The overall analyzed number of participants are from the ITT population. | Posted | Least Squares Mean | Standard Error | score on a scale | Visit 4 (Day 4), Non-CAE | Study Eye | Study Eye |
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| Secondary | Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain) | Ocular Surface Disease Index (OSDI) Questions 3: Have you experienced painful or sore eyes during the last week? on 0-4 Scale where 4 is the worst at pre-CAE® | The measurements are reported for each visit. The number of subjects in each group varied slightly at each visit. The overall number analyzed are reported based on the ITT population. - | Posted | Least Squares Mean | Standard Error | score on a scale | Visit 6 (Day 15) Pre-CAE | Study Eye | Study Eye |
|
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|
|
| Secondary | Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire | The Ora Calibra® Ocular Discomfort & 4-Symptom Questionnaire is used, which includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Each symptom rating ranges from 0 to 5, where 0 = None and 5 = Worst. Higher score means worse symptom. Min score = 0, max score = 25. | The measurements are reported for each visit. The number of subjects in each group varied slightly at each visit. The overall analyzed number of participants were from the ITT population | Posted | Least Squares Mean | Standard Error | score on a scale | Visit 6 (Day 15) Pre-CAE | Study Eye | Study Eye |
|
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|
|
| Post-Hoc | Change From Baseline in Fluorescein Staining in the Total Eye Sum - Both Eyes Together | The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate inferior, superior, central, temporal, and nasal region. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The corneal sum score is the sum of scores from the inferior, superior, and central regions (min 0, max 12). The conjunctival sum score is the sum of scores from the nasal and temporal regions (min 0, max 8). The total eye score is the sum of scores from all five regions (min 0, max 20). The average values of both eyes assessment were reported (min 0, max 20) | The analysis was done on both study and fellow eyes combined | Posted | Mean | Standard Deviation | units on a scale | Visit 7 (Day 28) Pre CAE | Eyes | Eyes |
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| Post-Hoc | Change From Baseline in Fluorescein Staining in Conjunctival Sum - Both Eyes Together | The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate inferior, superior, central, temporal, and nasal region. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The corneal sum score is the sum of scores from the inferior, superior, and central regions (min 0, max 12). The conjunctival sum score is the sum of scores from the nasal and temporal regions (min 0, max 8). The total eye score is the sum of scores from all five regions (min 0, max 20). The average values of both eyes assessment were reported (min 0, max 20). | The analysis was done on both study and fellow eyes combined | Posted | Mean | Standard Deviation | units on a scale | Visit 7 (Day 28), Pre CAE | Total Eyes | Total Eyes |
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| Post-Hoc | Change From Baseline in Fluorescein Staining in the Temporal Region - Both Eyes Together | The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate inferior, superior, central, temporal, and nasal region. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. This assessment reported the staining score in temporal region using the Corneal and Conjunctival Fluorescein Staining Scale (min 0, max 4). The average values of both eyes assessment were reported (min 0, max 4). | The count is based on the study and fellow eyes combined | Posted | Mean | Standard Deviation | units on a scale | Visit 7 (Day 28), Pre-CAE | Total Eyes | Total Eyes |
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| Post-Hoc | Change From Baseline in Ocular Discomfort Scale (Ora Calibra Scale) During the CAE - Area Under the Curve | Ocular Discomfort Scale is graded using the Ora Calibra Ocular Discomfort Scale (ODS). The scale ranges from 0 means no discomfort to 4 means worst discomfort. Higher score indicates more discomfort. Area under the curve is presented. AUC at each visit is calculated as follows: Calculate (time point - previous time point)*0.5*(discomfort score at time point + previous discomfort score at time point) then sum all of those values together. Given that this was taken every 5 minutes from 0 to 90 minutes, the maximum value for AUC would then be (5*0.5*8)*18=360, and the minimum value would be (5*0.5*0)*18=0. Given this, the minimum and maximum change from baseline would be -360 to 360. | Analysis was done on ITT population with Observed Data Only. The number analyzed in one or more rows differs from overall number analyzed because the number of participants/study eye analyzed can vary with each visit. | Posted | Least Squares Mean | Standard Error | Score on a scale*min | Baseline, Visit 5 (Day 7), Visit 6 (Day 14), and Visit 7 (Day 28) | Study Eye | Study Eye |
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| 0 |
| 52 |
| 1 |
| 52 |
| 6 |
| 52 |
| EG001 | High Dose ST-100 Ophthalmic Solution | High Dose ST100-001 Ophthalmic Solution, 50mg/ml ST-100 Ophthalmic Solution: One drop in each eye twice a day | 0 | 53 | 0 | 53 | 6 | 53 |
| EG002 | Placebo Ophthalmic Solution | Placebo Ophthalmic Solution (vehicle) Placebo Ophthalmic Solution: One drop in each eye twice a day | 1 | 54 | 2 | 54 | 8 | 54 |
| EG003 | Run-In | Run-In Phase | 0 | 160 | 0 | 160 | 0 | 160 |
| Poor organ function | General disorders | Non-systematic Assessment | Kidney, heart, liver |
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| Cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Instillation site pain | General disorders | Non-systematic Assessment |
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| Change from Baseline to Visit 5 (Day 7), 45 Minutes |
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| Change from Baseline to Visit 5 (Day 7), 90 Minutes |
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| Change from Baseline to Visit 6 (Day 14), 5 Minutes |
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| Change from Baseline to Visit 6 (Day 14), 45 Minutes |
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| Change from Baseline to Visit 6 (Day 14), 90 Minutes |
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| Change from Baseline to Visit 7 (Day 28), 5 Minutes |
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| Change from Baseline to Visit 7 (Day 28), 45 Minutes |
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| Change from Baseline to Visit 7 (Day 28), 90 Minutes |
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