A clinical trial Comparing Diquafosol and Rebamipide in Dry Eye Disease
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0008866
- Lead Sponsor
- Yonsei University, Wonju Severance Christian Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
Adult men and women over 19 years of age
- Patients with dry eye syndrome for at least 3 months
- Patients who satisfy all of the following criteria in at least one of both eyes at the time of screening
: Ocular surface staining score of 1 or more
: Tear film break up time less than 10 seconds
: Schirmer test without anesthesia 10 mm/5 minutes or less
- Clinically significant corneal surface disease not attributable to dry eye symptoms
- Abnormal eyelid function
- Laser refractive surgery within the past 12 months and ophthalmic surgery within the past 3 months
- Punctum plug or lacrimal occlusion has been performed or is being planned within the past 3 months
- If systemic steroids, immunosuppressants, topical steroids or cyclosporine have been used within 4 weeks
- Those who use other drugs that can affect dry eye syndrome and have started taking the drug within the past 4 weeks or have changed the dose
- If the intraocular pressure in one or more of both eyes exceeds 22 mmHg or has glaucoma requiring treatment
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Ocular Surface Disease Index (OSDI) score after 4 weeks compared to baseline Changes in Tear Break Time Test (TBUT) scores after 4 weeks compared to baseline
- Secondary Outcome Measures
Name Time Method Conjunctival staining score, corneal staining score, tear film matrix metalloproteinase 9 (MMP9), tear film osmolarity, non-invasive tear film breakup time test (NIBUT), lipid layer thickness test (LLT), tear meniscus height test ( TMH), drug side effects and satisfaction questionnaire, Convenience, effectiveness, and a questionnaire to choose among two drugs that you want to use in the future