Immediate Therapeutic Effects of Diquafosol and Rebamipide in Dry Eye Disease

Korea University

Status and phase: Completed; Phase 4

Conditions: Dry Eye Disease (DED)

Treatments: Drug: 3% diquafosol (right eye) and 2% rebamipide (left eye); Drug: 2% rebamipide (right eye) and 3% diquafosol (left eye)

Study type: Interventional

Funder types: Other

Identifiers

NCT07297316

2022AN0535

Details and patient eligibility

About

This study compares the immediate therapeutic and mucin-secreting effects 30 minutes after instillation of 3% diquafosol and 2% rebamipide in dry eye disease.

Enrollment: 30 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients 19 years or older
• complaint of at least one dry eye symmptom and tear breakup time < 7 seconds

Exclusion criteria

• Sjogren's syndrome
• prescription history of systemic steroids or immunosuppressants
• prior ocular surgery within six months of enrollment
• treatment with diquafosol or rebamipide eye drops within 2 weeks of enrollment
• treatment with punctal plug within 1 month of enrollment
• intraocular pressure exceeding 25mmHg
• usage of contact lens during the study
• active ocular infection
• pregnancy or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 2 patient groups

R) DQS, L) REB

Other group

Description:

This is a paired-eye design study. Patients were randomly assigned to receive 3% diquafosol in the right eye and 2% rebamipide in the contralateral left eye, with the treatment assignment blinded to the examiner and patients.

Treatment:

Drug: 3% diquafosol (right eye) and 2% rebamipide (left eye)

R) REB, L) DQS

Other group

Description:

This is a paired-eye design study. Patients were randomly assigned to receive 3% diquafosol in the left eye and 2% rebamipide in the contralateral right eye, with the treatment assignment blinded to the examiner and patients.

Treatment:

Drug: 2% rebamipide (right eye) and 3% diquafosol (left eye)