Phase 2
N=84
Dry Eye Disease Study With Brimonidine
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT03418727 ↗Enrolled (actual)
84
Serious AEs
2.4%
Results posted
Jul 2022
Primary outcome: Primary: Tolerance of Test Substance Visual Analogue Scale (VAS) Score — 82.1; 87.0; 95.0; 91.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Brimonidine (Drug); Brimonidine Mono Therapy (Drug); sodium carboxymethylcellulose (Drug); Corticosteroid Eye Drop (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ocugen
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerance of Test Substance Visual Analogue Scale (VAS) Score |
82.1; 87.0; 95.0; 91.1; 87.4; 88.2 | — |
Summary
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).
Eligibility Criteria
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 /= 25 mm at both Screening and Baseline (Day 1) visits
- Intraocular pressure (IOP) >/= 5 mmHg and 22 mmHg in either eye
- Active ocular infection or history of ocular herpetic keratitis
- History of neurotrophic keratitis or ocular neuropathic pain
- Any history of eyelid surgery or intraocular/ocular surgery within the past 3 months
- Punctal occlusion within 3 months prior to Screening visit or during study
- Corneal epithelial defect larger than 1 mm2 in either eye
- Have active drug/alcohol dependence or abuse history
- Are neonates, pregnant/lactating women, children, institutionalized individuals, or others who may be considered vulnerable populations
- Received corticosteroid-containing eye drops within the past 7 days or systemic corticosteroids/immunosuppressives within the past 3 months
- Received cyclosporine ophthalmic emulsion 0.05% (Restasis®) or lifitegrast ophthalmic solution 5% (Xiidra™) within 30 days prior to Screening visit
- In the opinion of Investigator or Study Coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops
- Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
Data sourced from ClinicalTrials.gov (NCT03418727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.