Trials / Completed
CompletedNCT01027013
Safety and Efficacy Study of Rebamipide 2% Ophthalmic Suspension in Patients With Dry Eye
A Phase II, Prospective, Randomized, Double-masked, Parallel Group, Multi-center Study Assessing the Safety and Efficacy of 2% Rebamipide (OPC-12759) Compared to Placebo for the Treatment of Keratoconjunctivitis Sicca (Dry Eye)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 220 (actual)
- Sponsor
- Kubota Vision Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of rebamipide 2% suspension for the treatment of patients with dry-eye.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rebamipide 2% ophthalmic suspension | Instill one drop in each eye four times daily for 12 weeks. |
| DRUG | placebo eye drops | Instill one drop in each eye four times daily for 12 weeks. |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2010-10-01
- Completion
- 2010-11-01
- First posted
- 2009-12-07
- Last updated
- 2012-01-11
Locations
5 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01027013. Inclusion in this directory is not an endorsement.