A clinical trial Comparing Diquafosol and Rebamipide in Dry Eye Disease

A Prospective, Randomized, Crossover trial Comparing Diquafosol and Rebamipide in Dry Eye Disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008866

Enrollment

Registered

2023-10-12

Start date

2022-12-13

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Randomly select one of the two drugs (Dicuafosol, Rebamipide) and use it in the form of eye drop 4 times a day for 4 weeks. After that, patients take 2 week withdrawal peiod. After the withdraw

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactYeonwoo Jin

Yonsei University, Wonju Severance Christian Hospital

foxwoo20@naver.com+82-33-741-0114

Outcome results