Last reviewed · How we verify
Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.
Details
| Lead sponsor | Allergan |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 82 |
| Start date | 2009-11 |
| Completion | 2010-09 |
Conditions
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
Interventions
- carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
- sodium hyaluronate 0.18% (VISMED® Multi)
Primary outcomes
- Change From Baseline in Global Ocular Staining Score at Day 35 — Baseline, Day 35
Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst).
Countries
France