The Effect of 3% Diquafosol Ophthalmic Solution on Visual Display Terminal-associated Dry Eye

Peking University

Status and phase: Unknown; Phase 4

Conditions: Computer Vision Syndrome; Dry Eye Syndromes; Asthenopia

Treatments: Drug: Diquafosol

Study type: Interventional

Funder types: Other

Identifiers

NCT04668118

Diquafosol

Details and patient eligibility

About

This study aims to evaluate the efficacy and safety of 3% Diquafosol Ophthalmic Solution for visual display terminal (VDT)-associated dry eye and to investigate the mechanism of treatment.

Full description

The treatment period is 12 weeks. The day after subjects who meet the inclusion criteria undergo baseline examination is the day starting the medication. The dosing frequency was six times daily for 3% Diquafosol Ophthalmic Solution. The follow-up time points are 2, 4, 8, 12 weeks, and the investigator will evaluate the symptoms and signs of Dry Eye.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female with a diagnosis dry eye based on Chinese Dry Eye Diagnosis Standard (2020)；
• Working in the offices with VDTs more than 4h daily；
• Working in the offices with VDTs at least five days per week；
• Provision of written informed consent.

Exclusion criteria

• Known allergy to any eye drops
• Ocular therapies other than artificial tears
• Presence of any of the following conditions: active ocular infection, ocular inflammation, active ocular allergy, contact lens wear, ocular surgical history, laser treatment in the last 3 months, Meibomian gland dysfunction (MGD) over grade 2 (the grade is according to the report of the International Workshop on MGD in 2011), severe blepharitis or obvious inflammation of the eyelid margin, which in the judgment of the investigator may interfere with the interpretation of the study results
• Pregnant and lactating women, or those planning a pregnancy over the course of the study
• Uncontrolled systemic disease
• Hypersensitivity or intolerance to diquafosol(DQS)
• Subjects with a history of anxiety and depression

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 1 patient group

Diquafosol group

Experimental group

Description:

The treatment period is 12 weeks. The day after subjects who meet the inclusion criteria undergo baseline examination is the day starting the medication. Dosing frequency was six times daily for 3% Diquafosol Ophthalmic Solution. The follow-up time points are 2, 4, 8, 12 weeks, and no other medication is required on the follow-up day.

Treatment:

Drug: Diquafosol