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To evaluate the tolerability and preliminary efficacy of Brimonidine eye drops (with and without corticosteroid eye drops) for the treatment of Dry Eye Disease (DED).
Subjects will assess their tolerance to the administration of the study drug, utilizing a Visual Analog Scale (VAS). The VAS is a 100-mm horizontal line with verbal descriptors at either end. The VAS ratings will be completed after administration of the study drug on Day 1 (post-dose), Day 28, Day 56, Day 84, and Day 105. Subjects will place a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Drug Arm #1 | Experimental | Combination Therapy: brimonidine (0.2%) administered as eye drops, followed by corticosteroid eye drops, two times a day (BID) for 12 weeks |
|
| Study Drug Arm #2 | Experimental | Monotherapy: brimonidine (0.2%) administered as eye drops followed by placebo, two times a day (BID) for 12 weeks |
|
| Control Arm | Placebo Comparator | Placebo: sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application, two time a day (BID) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brimonidine | Drug | Two products delivered in sequence twice daily. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of Test Substance Visual Analogue Scale (VAS) Score | Participants assessed their tolerance to the administration of the study drug, utilizing a VAS. The VAS is a 100-mm horizontal line with verbal descriptors at either end. Participants placed a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm). | Days 1, 28, 56, and 84 |
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Inclusion Criteria:
Aged 18 years or older.
Sign and date informed consent form approved by the IRB
History of Dry Eye Disease
Objective evidence of DED in at least one eye by having 2 or more of the following 4 signs in the same eye at Screening and Baseline (Day 1) visits:
i. Conjunctival staining at >/= 1 (out of a possible score of 6 per eye) ii. Corneal staining at >/= 2 (out of a possible score of 15 per eye) iii. Noninvasive Tear Break-Up Time (NITBUT) at </= 7 seconds iv. Schirmer test at <10mm in 5 minutes
Symptomatic evidence of DED by having a global symptom score (SANDE) >/= 25 mm at both Screening and Baseline (Day 1) visits
Intraocular pressure (IOP) >/= 5 mmHg and </= 22 mmHg in each eye
Women who satisfy one of the following:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chicago Cornea Consultants | Hoffman Estates | Illinois | 60169 | United States | ||
| Brenart Eye Clinic |
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| ID | Title | Description |
|---|---|---|
| FG000 | Brimonidine and Corticosteroid Combination Therapy | Brimonidine (0.2%) administered as eye drops, followed by loteprednol ophthalmic suspension (0.2%), two times a day (BID) for 12 weeks |
| FG001 | Brimonidine Monotherapy | Brimonidine (0.2%) administered as eye drops followed by placebo BID for 12 weeks |
| FG002 | Placebo | Sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application BID for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Randomized population including all participants who were randomized to the treatment
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| ID | Title | Description |
|---|---|---|
| BG000 | Brimonidine and Corticosteroid Combination Therapy | Brimonidine (0.2%) administered as eye drops, followed by loteprednol ophthalmic suspension (0.2%) BID for 12 weeks |
| BG001 | Brimonidine Monotherapy |
| 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 | Tolerance of Test Substance Visual Analogue Scale (VAS) Score | Participants assessed their tolerance to the administration of the study drug, utilizing a VAS. The VAS is a 100-mm horizontal line with verbal descriptors at either end. Participants placed a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm). | Safety population that included all randomized participants who received at least one dose of study medication. Here, the overall number of participants analyzed are those evaluable for this Outcome Measure and the Number Analyzed per Row is the number of participants with evaluable data at each time point. | Posted | Mean | 90% Confidence Interval | score on a scale | Days 1, 28, 56, and 84 |
|
Day 1 (post-dose) up to 105 Days
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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 | Brimonidine and Corticosteroid Combination Therapy | Brimonidine (0.2%) administered as eye drops, followed by loteprednol ophthalmic suspension (0.2%) BID for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vijay Tammara, VP, Strategic Regulatory Operations | Ocugen | 484-328-4751 | Vijay.tammara@ocugen.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 | Oct 25, 2017 | Jun 10, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2018 | Jun 10, 2022 | 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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| ID | Term |
|---|---|
| D000068438 | Brimonidine Tartrate |
| D002266 | Carboxymethylcellulose Sodium |
| ID | Term |
|---|---|
| D011810 | Quinoxalines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Brimonidine Mono Therapy |
| Drug |
Brimonidine given twice daily along with placebo drops |
|
| sodium carboxymethylcellulose | Drug | Placebo given twice daily. |
|
| Corticosteroid Eye Drop | Drug | Eye drop to be administered after Brimonidine in treatment arm 1 |
|
| Yorkville |
| Illinois |
| 60560 |
| United States |
| The Eye Institute of Utah | Salt Lake City | Utah | 84107 | United States |
Brimonidine (0.2%) administered as eye drops followed by placebo BID for 12 weeks
| BG002 | Placebo | Sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application BID for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Brimonidine Monotherapy | Brimonidine (0.2%) administered as eye drops followed by placebo BID for 12 weeks |
| OG002 | Placebo | Sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application BID for 12 weeks |
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| 0 |
| 29 |
| EG001 | Brimonidine Monotherapy | Brimonidine (0.2%) administered as eye drops followed by placebo BID for 12 weeks | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | Placebo | Sodium carboxymethylcellulose (0.25%) administered as eye drops followed by a second application BID for 12 weeks | 0 | 27 | 1 | 27 | 0 | 27 |
| Knee operation | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
|
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| D008747 | Methylcellulose |
| D002482 | Cellulose |
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |