Trials / Completed
CompletedNCT01768312
Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group
A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group 12 Weeks After Treatment in Moderate to Severe Dry Eye Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- Hanlim Pharm. Co., Ltd. · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
A Multicenter, Randomized, Double-blind Phase Ⅲ Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group 12 Weeks After Treatment in Moderate to Severe Dry Eye Disease
Detailed description
The purpose of this clinical Study is Tisporin Eye Drops 0.05%(Cyclosporine ophthalmic solution) group and Restasis Eye Drops 0.05%(Cyclosporine ophthalmic suspension) group 12 weeks after treatment, each treatment group comparisons for evaluation of efficacy and safety in Moderate to Severe Dry Eye Disease. \- Corneal staining test, Ocular surface disease index (OSDI), Tear break up time (TBUT), Non-anesthetic Schirmer test
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cyclosporine ophthalmic solution | 1 drop twice/day for 12 weeks to both eyes |
Timeline
- Start date
- 2012-08-23
- Primary completion
- 2013-07-31
- Completion
- 2013-07-31
- First posted
- 2013-01-15
- Last updated
- 2018-08-29
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01768312. Inclusion in this directory is not an endorsement.