Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
|ClinicalTrials.gov Identifier: NCT02254265|
Recruitment Status : Completed
First Posted : October 1, 2014
Results First Posted : December 14, 2018
Last Update Posted : May 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Keratoconjunctivitis Sicca Dry Eye Disease||Drug: OTX-101 0.05% Drug: OTX-101 0.09% Drug: Vehicle||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||455 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Multicenter, Double-Masked, Vehicle-Controlled, Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
Experimental: OTX-101 0.05%
OTX-101 0.05% ophthalmic solution 1 drop in both eyes BID for 84 days
Drug: OTX-101 0.05%
OTX-101 0.05% Ophthalmic Solution
Experimental: OTX-101 0.09%
OTX-101 0.09% ophthalmic solution 1 drop in both eyes BID for 84 days
Drug: OTX-101 0.09%
OTX-101 0.09% Ophthalmic Solution
Placebo Comparator: Vehicle
Vehicle of OTX-101 ophthalmic solution 1 drop in both eyes BID for 84 days
Vehicle of OTX-101 Ophthalmic Solution
- 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
- Tear Film Break up Time (TBUT) [ Time Frame: Baseline to 84 days ]Mean change from baseline in TBUT in the study eye from baseline at Day 84
- Corneal Staining Score [ Time Frame: Baseline to 84 days ]Mean Change from Baseline in Corneal Staining Score in the Study Eye. Expanded National Eye Institute Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale
- Schirmer's Test [ Time Frame: Baseline to 84 days ]
Change from Baseline in Categorized Schirmer's Test Score. Schirmer's test was performed with strips placed in both eyes at the same time. Strips were removed after 5 minutes and the amount of wetting (in mm) was recorded as scores from 1 to 5.
1: < 3 mm, 3 - 6 mm, 7 - 10 mm, 11 - 14 mm, and 5: > 14 mm
- Patient Satisfaction [ Time Frame: Baseline to 84 days ]Patient satisfaction with treatment score using 5-point scale (1=extremely dissatisfied to 5=extremely satisfied)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254265
|United States, Ohio|
|Cleveland, Ohio, United States|