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

NCT04668118 | Unknown Phase 4

• 1 other identifier: Diquafosol
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye Syndromes; Computer Vision Syndrome; Asthenopia

Outcome Measures

Primary Outcomes (2)

• the changes of Ocular Surface Disease Index (OSDI) scores

  OSDI is one of the most frequently used questionnaires for evaluation of Dry eye disease(DED). This includes 12 questions which measure the frequency of symptoms over the recent week, and the scores range from 0 to 100. The higher the score, the worse the result.

  12 weeks after intervention

• the changes of Tear break-up time (TBUT)

  TBUT is the time from normal blinking to the first appearance of a break in the tear film. The BUT was measured using fluorescein with a metronome, and the average of three consecutive BUTs was calculated. The shorter the TBUT, the worse the outcome.

  12 weeks after intervention

Secondary Outcomes (5)

• the changes of scores of Corneal fluorescein staining (CFS)

  12 weeks after intervention

• the changes of scores of Lissamine green staining

  12 weeks after intervention

• the changes of value of Schirmer Ⅰ test (SⅠt)

  12 weeks after intervention

• the changes of Lipid layer thickness(LLT)

  12 weeks after intervention

• the changes of Partial blink rate(PBR)

  12 weeks after intervention

Study Arms (1)

Diquafosol group

EXPERIMENTAL

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.

Drug: Diquafosol

Interventions

Diquafosol 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.

Also known as: Diquafosol Sodium Eye Drops, 3% Diquafosol Ophthalmic Solution

Diquafosol group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes; Asthenopia

Interventions

diquafosol

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Tingting Yang, MD

  Peking University Third Hospital

  STUDY DIRECTOR

Central Study Contacts

Hong Qi, Phd

CONTACT

010-13901066889; doctorqihong@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 16, 2020
• Study Start: February 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: March 25, 2023
• Last Updated: June 1, 2022

Record last verified: 2022-04

Locations

CN (1)