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Brimonidine · 2 trials · 1 indication
The SANDE questionnaire is a short Visual Analog Scale (VAS) assessment that quantifies both severity and frequency of current dry eye symptoms. The SANDE is comprised of two questions, and each question employs a 100-mm horizontal linear VAS. The measurement of symptom frequency ranges from "rarely" to "all of the time", and the symptom severity from "very mild" to "very severe". Data collected from the SANDE questionnaire was calculated by multiplying the frequency score by the severity score and obtaining the square root. The result is the Overall SANDE score which ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms.
Conjunctival staining with Lissamine Green dye (1%; LG) staining in each eye was conducted using the slit lamp. A single drop of 1% Lissamine Green dye was applied to the inferior conjunctival fornix of both eyes. The conjunctivae was examined with the slit lamp at ×10 magnification, using a neutral-density filter. The conjunctiva was graded for each eye from 0 to 3 based on the density of punctate staining in the nasal-bulbar and temporal-bulbar zones. Total scores ranged from 0 (no staining) to 6 (most severe staining) with a lower score representing a more desirable outcome.
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).
| Arm | Type | Description |
|---|---|---|
| OCU-310 | EXPERIMENTAL | Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks |
| Placebos | PLACEBO_COMPARATOR | Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks |
| 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 |
|---|---|---|
| Brimonidine Tartrate | DRUG | Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks. |
| Placebos | DRUG | Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks. |
| Brimonidine | DRUG | Two products delivered in sequence twice daily. |
| 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 |
Inclusion Criteria: 1. Aged 18 years or older. 2. Sign and date informed consent form approved by the IRB 3. History of Dry Eye Disease for ≥6 months 4. Demonstrate the following 2 signs of DED in the same eye at Screening and Baseline (Day 1): 1. Conjunctival staining at ≥3 (out of a possible ...
Brimonidine is an investigational small molecule being developed for the treatment of dry eye disease. It is formulated as a brimonidine tartrate nanoemulsion eye drop solution. The drug is currently in Phase 3 clinical development for this indication.
Brimonidine is being developed by Ocugen, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol OCGN. The company is advancing the drug as a potential treatment for dry eye disease.
Brimonidine is in Phase 3 clinical development for dry eye disease. It has completed two clinical trials, including a Phase 2 study and a Phase 3 study, both conducted in the United States. The drug remains investigational and has not been approved by the FDA.
Brimonidine has been studied in two completed clinical trials for dry eye disease. The first, NCT03418727, was a Phase 2 study with 84 participants. The second, NCT03785340, was a Phase 3 study with 252 participants. Both trials were randomized, double-blind, and placebo-controlled.
Brimonidine is a small molecule that acts as an alpha-2 adrenergic receptor agonist. In the context of dry eye disease, it is being studied as a nanoemulsion eye drop solution. The specific mechanism by which it may alleviate dry eye symptoms is under investigation.
Brimonidine is not FDA approved for dry eye disease. It is an investigational drug currently in Phase 3 clinical development. While two clinical trials have been completed, the drug has not yet received regulatory approval for this indication.