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

Primary Purpose

Dry Eye Syndromes, Computer Vision Syndrome, Asthenopia

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Diquafosol
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diquafosol group

Arm 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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
December 6, 2020
Last Updated
May 31, 2022
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04668118
Brief Title
The Effect of 3% Diquafosol Ophthalmic Solution on Visual Display Terminal-associated Dry Eye
Official Title
The Effect of 3% Diquafosol Ophthalmic Solution on Visual Display Terminal-associated Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
March 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Computer Vision Syndrome, Asthenopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diquafosol group
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Diquafosol
Other Intervention Name(s)
Diquafosol Sodium Eye Drops, 3% Diquafosol Ophthalmic Solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
the changes of Ocular Surface Disease Index (OSDI) scores
Description
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.
Time Frame
12 weeks after intervention
Title
the changes of Tear break-up time (TBUT)
Description
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.
Time Frame
12 weeks after intervention
Secondary Outcome Measure Information:
Title
the changes of scores of Corneal fluorescein staining (CFS)
Description
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.
Time Frame
12 weeks after intervention
Title
the changes of scores of Lissamine green staining
Description
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.
Time Frame
12 weeks after intervention
Title
the changes of value of Schirmer Ⅰ test (SⅠt)
Description
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.
Time Frame
12 weeks after intervention
Title
the changes of Lipid layer thickness(LLT)
Description
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.
Time Frame
12 weeks after intervention
Title
the changes of Partial blink rate(PBR)
Description
PBR can be provided by Lipiview interferometer, which mainly evaluate incomplete blinking. The higher the rate, the worse the result.
Time Frame
12 weeks after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hong Qi, Phd
Phone
010-13901066889
Email
doctorqihong@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tingting Yang, MD
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Qi, MD
Email
doctorqihong@163.com

12. IPD Sharing Statement

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

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