Clinical Trial: Phase 2/3 Dose-Ranging Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Ocular Technologies SARL

Current Primary Outcome:

  • Conjunctival staining [ Time Frame: 84 days ]
    Mean change from baseline at day 84 for the lissamine green conjunctival staining score in the designated study eye
  • Global symptom score [ Time Frame: 84 days ]
    Mean change from baseline at day 84 for the global symptom score


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tear film break up time (TBUT) [ Time Frame: 84 days ]
    Mean change from baseline in TBUT in the study eye from baseline at Day 84
  • Clearing of corneal staining [ Time Frame: 84 days ]
    Proportion of subjects with complete clearing of corneal fluorescein staining in the study eye at Day 84
  • Reduction in conjunctival staining [ Time Frame: 84 days ]
    Proportion o subjects demonstrating a greater than or equal to 30% reduction in lissamine green conjunctival staining in the study eye from baseline to Day 84
  • Change from baseline [ Time Frame: 56 days ]
    Mean change from baseline at days 14, 28, 42 and 56 for lissamine green conjunctival staining score, global symptom score and TBUT
  • Schirmers Test [ Time Frame: 84 days ]
    Proportion of subjects demonstrating an increase of greater than or equal to 10 mm in Schirmer's test score from baseline to day 84
  • Safety and tolerability [ Time Frame: 84 days ]
    Evaluation of incidence of adverse events and assessment of tolerability


Original Secondary Outcome:

  • Tear film break up time [ Time Frame: 84 days ]
    Mean change from baseline in TBUT in the study eye from baseline at Day 84
  • Clearing of corneal staining [ Time Frame: 84 days ]
    Proportion of subjects with complete clearing of corneal fluorescein staining in the study eye at Day 84
  • Reduction in conjunctival staining [ Time Frame: 84 days ]
    Proportion o subjects demonstrating a greater than or equal to 30% reduction in lissamine green conjunctival staining in the study eye from baseline to Day 84
  • Change from baseline [ Time Frame: 56 days ]
    Mean change from baseline at days 14, 28, 42 and 56 for lissamine green conjunctival staining score, global symptom score and TBUT
  • Schirmers Test [ Time Frame: 84 days ]
    Proportion of subjects demonstrating an increase of greater than or equal to 10 mm in Schirmer's test score from baseline to day 84
  • Safety and tolerability [ Time Frame: 84 days ]
    Evaluation of incidence of adverse events and assessment of tolerability


Information By: Ocular Technologies SARL

Dates:
Date Received: September 29, 2014
Date Started: September 2014
Date Completion:
Last Updated: November 18, 2016
Last Verified: November 2016