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

NCT ID: NCT04668118

Last Updated: 2022-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2023-03-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dry Eye Syndromes Computer Vision Syndrome Asthenopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diquafosol group

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.

Group Type EXPERIMENTAL

Diquafosol

Intervention Type DRUG

As a P2Y2 receptor agonist, diquafosol can be used to stabilize the tear film by stimulating P2Y2 receptors on the corneal epithelial cells and conjunctival goblet cell, which increase the secretion of tear fluid and mucin on the ocular surface, thereby repairing the ocular surface and stabilizing the tear film.

Interventions

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Diquafosol

As a P2Y2 receptor agonist, diquafosol can be used to stabilize the tear film by stimulating P2Y2 receptors on the corneal epithelial cells and conjunctival goblet cell, which increase the secretion of tear fluid and mucin on the ocular surface, thereby repairing the ocular surface and stabilizing the tear film.

Intervention Type DRUG

Other Intervention Names

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Diquafosol Sodium Eye Drops 3% Diquafosol Ophthalmic Solution

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tingting Yang, MD

Role: STUDY_DIRECTOR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hong Qi, Phd

Role: CONTACT

010-13901066889

Facility Contacts

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Hong Qi, MD

Role: primary

Other Identifiers

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Diquafosol

Identifier Type: -

Identifier Source: org_study_id

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