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

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Syndromes; Computer Vision Syndrome; Asthenopia
• Intervention / Treatment: Drug: Diquafosol

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 68
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hong Qi, Phd; Phone Number: 010-13901066889; Email: doctorqihong@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: 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.; Other Names: Diquafosol Sodium Eye Drops; 3% Diquafosol Ophthalmic Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the changes of scores of Corneal fluorescein staining (CFS)	The degree of fluorescein staining of the cornea was evaluated using the National Eye Institute (NEI) scale of five corneal regions (central, superior, temporal, nasal, and inferior). The degree of staining in each of the five regions was graded on a scale of 0-3 according to the NEI/Industry Workshop method: 0 =no staining, 1 =mild staining, 2 = moderate staining, and 3 = severe staining. The maximal score for each area was 3. The scores of the five areas were added to obtain a total score for each eye. The higher the score, the worse the result.	12 weeks after intervention
the changes of scores of Lissamine green staining	To grade the temporal zone, the subject looks nasally; to grade the nasal zone the subject looks temporally. The upper and lower conjunctiva can also be graded. The higher the score, the worse the result.	12 weeks after intervention
the changes of value of Schirmer Ⅰ test (SⅠt)	The Schirmer I test is performed using sterile strips without anesthesia. The strips are placed in the lateral part of the inferior fornix of the eye for 5min and the extent of tear flow down was measured in millimeters. The higher the value, the better the result.	12 weeks after intervention
the changes of Lipid layer thickness(LLT)	Lipid layer is evaluated by Lipiview interferometer (TearScience Inc, Morrisville, NC, USA) which records a 15-s live digital image of the interference pattern of the tear film. The interferometry color units (ICU) of the tear film which is an indicator of lipid layer thickness is assessed according to the mean interference color pattern through specular reflection. The higher the thickness, the better the result.	12 weeks after intervention
the changes of Partial blink rate(PBR)	PBR can be provided by Lipiview interferometer, which mainly evaluate incomplete blinking. The higher the rate, the worse the result.	12 weeks after intervention

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Director: Tingting Yang, MD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): March 25, 2023

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Asthenopia; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: Diquafosol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No