The Efficacies and Safeties of a 0.05% Cyclosporine Nanoemulsion and a 0.1% Cyclosporine Cationic Emulsio
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0007916
- Lead Sponsor
- Kangbuk Samsung Medical Center
- Brief Summary
The corneal staining scores and the TBUT and Schirmer test results showed that both groups showed significant improvements. The corneal staining scores significantly (and similarly) decreased in both groups. In the test group, the TBUT showed significant prolongation after 1 month of treatment and the Schirmer test score increased significantly after 3 months. Both groups reported less ocular discomfort and better compliance with drug use at 3 months than 1 month; the control group demonstrated a significant decrease in ocular discomfort at 3 month
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 105
1. age above 19 years
2. Patients diagnosed with moderate to severe dray eye disease
- ocular staining score = 3 or
- TBUT =10 sec
3. possible to follow-up more than 3 monts
4. the patient who agree to participate in the study voluntarily
1. patients using cyclosporine or used within 1 month
2. patients with active ocular infection such as Stevens-Johnson syndrome
3. history of corneal transplantation or neurotrophic keratitis
4. patients with ocular disease which can affect the result of study
5. patients with allergic reaction to cyclosporine
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy of 0.05% cyclosporine Nanoemulsion
- Secondary Outcome Measures
Name Time Method TBUT, NEI scale, Schirmer test