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

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ClinicalTrials.gov Identifier: NCT04668118
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Computer Vision Syndrome Asthenopia Drug: Diquafosol Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of 3% Diquafosol Ophthalmic Solution on Visual Display Terminal-associated Dry Eye
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : March 25, 2023
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. the changes of Ocular Surface Disease Index (OSDI) scores [ Time Frame: 12 weeks after intervention ]
    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.

  2. the changes of Tear break-up time (TBUT) [ Time Frame: 12 weeks after intervention ]
    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.


Secondary Outcome Measures :
  1. the changes of scores of Corneal fluorescein staining (CFS) [ Time Frame: 12 weeks after intervention ]
    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.

  2. the changes of scores of Lissamine green staining [ Time Frame: 12 weeks after intervention ]
    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.

  3. the changes of value of Schirmer Ⅰ test (SⅠt) [ Time Frame: 12 weeks after intervention ]
    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.

  4. the changes of Lipid layer thickness(LLT) [ Time Frame: 12 weeks after intervention ]
    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.

  5. the changes of Partial blink rate(PBR) [ Time Frame: 12 weeks after intervention ]
    PBR can be provided by Lipiview interferometer, which mainly evaluate incomplete blinking. The higher the rate, the worse the result.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04668118


Contacts
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Contact: Hong Qi, Phd 010-13901066889 doctorqihong@163.com

Locations
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China, Beijing
Peking University Third Hospital Recruiting
Beijing, Beijing, China, 100191
Contact: Hong Qi, MD       doctorqihong@163.com   
Sponsors and Collaborators
Peking University Third Hospital
Investigators
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Study Director: Tingting Yang, MD Peking University Third Hospital
More Information
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04668118    
Other Study ID Numbers: Diquafosol
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: April 2022

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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
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Asthenopia
Syndrome
Disease
Pathologic Processes
Lacrimal Apparatus Diseases
Eye Diseases
 Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Ophthalmic Solutions
Pharmaceutical Solutions