A Randomized, Multicenter, Double-Masked, Vehicle-Controlled, Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Overview
- Phase
- Phase 2
- Intervention
- OTX-101 0.05%
- Conditions
- Keratoconjunctivitis Sicca
- Sponsor
- Sun Pharmaceutical Industries Limited
- Enrollment
- 455
- Primary Endpoint
- Conjunctival Staining
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a Phase 2/3 study to evaluate the safety and efficacy of 2 different dose concentrations of OTX-101 dosed twice a day in both eyes for 84 days compared to placebo (vehicle) in patients with keratoconjunctivitis sicca (dry eye disease).
Detailed Description
Keratoconjunctivitis sicca (KCS) is a common multifactorial ophthalmologic disorder of the tears and ocular surface characterized by symptoms of burning, stinging, itching, grittiness, scratchiness, foreign body sensation, dryness, stickiness and tired eye sensation. This study is the first clinical safety and efficacy study with OTX-101 and is designed to compare two dose concentrations of OTX-101 against vehicle (placebo) in reducing the signs and symptoms of KCS and evaluate safety when dosed twice a day in both eyes over an 84 day period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects age 18 years or older on the date of informed consent.
- •All subjects must provide signed written consent prior to participation in any study-related procedures.
- •Patient-reported history of KCS for a period of at least 6 months.
- •Clinical diagnosis of bilateral KCS supported by OTX-101-2014-001 study assessments.
- •Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at Screening and Baseline.
- •Global symptom score ≥ 40 at both Screening and Baseline.
- •Corrected Snellen VA of better than 20/200 in each eye.
- •Willing to discontinue use of current dry eye therapy (including artificial tears or ocular lubricants) during the study as of the run-in period.
- •Female subjects of childbearing potential must have a negative urine pregnancy test at Screening. Women of childbearing potential (ie, women who are not either postmenopausal for one year or surgically sterile) must use an acceptable form of contraception throughout the study.
Exclusion Criteria
- •Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to Screening.
- •Previous treatment failure (lack of efficacy) on cyclosporine ophthalmic emulsion 0.05% (Restasis).
- •Diagnosed with Sjögren's disease ˃5 years prior to Screening.
- •Clinical diagnosis of seasonal and perennial allergic conjunctivitis.
- •Use of systemic and topical medications that are known to cause dry eye within 7 days prior to Screening and throughout the study period. These include the following medications:
- •Immunomodulators (permitted if dose is stable for 3 months prior to screening and does not change during the study period)
- •Antihistamines (including over-the counter (OTC))
- •Cholinergics
- •Antimuscarinics
- •Tricyclic antidepressants
Arms & Interventions
OTX-101 0.05%
OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days
Intervention: OTX-101 0.05%
OTX-101 0.09%
OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days
Intervention: OTX-101 0.09%
Vehicle
Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days
Intervention: Vehicle
Outcomes
Primary Outcomes
Conjunctival Staining
Time Frame: Baseline to 84 days
Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye. The Investigator recorded a score for each area of each eye on a 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots) scale
Global Symptom Score
Time Frame: Baseline to 84 days
Mean change from baseline at day 84 for the global symptom score. The freuency and severy of dry eye and irritation scores were used to calculate symptom score as follows: Frequency of dry eye/irritation based on a scale of 0 (rarely) to 100 (all the time) Severity of dryness or irritation based on a scale of 0 (very mildly) to 100 (very severe). The global symptom score was calculated as the square root of the frequency score times the severity score
Secondary Outcomes
- Corneal Staining Score(Baseline to 84 days)
- Schirmer's Test(Baseline to 84 days)
- Patient Satisfaction(Baseline to 84 days)
- Tear Film Break up Time (TBUT)(Baseline to 84 days)