Effects of 3% Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye

August 8, 2024 updated by: He Eye Hospital
Investigate the effect of 3% Diquafosol on tear film and vision-related quality of life in dry eye patients wearing orthokeratology lenses(OK lens), and to provide reference for clinical treatment.This prospective, open label study will include 60 eyes of 30 OK lens related dry eye patients.Participants will receive 3% Diquafosol ophthalmic solution. The dosage for both drugs will be one drop, six times per day for 4 weeks. Pediatric Refractive Error Profiletear(PREP), tear film lipid layer (TFLL),non-invasive breakup time (NITBUT), corneoconjunctival staining score (CS), tear meniscus height (TMH), objective visual quality,ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Keratoplasty is gaining popularity worldwide as a method of controlling myopia progression. Several clinical studies have shown that overnight wear of Orthokeratology lenses (OK) is an effective method of slowing myopia progression in adolescents.However, wearing corneal contact lenses tends to interfere with tear homeostasis, which may lead to ocular discomfort, dryness, and ocular surface disorders. More than 50% of contact lens wearers report symptoms of dry eye.Prolonged contact with the cornea can have an effect on the corneal layer.With the rapid increase in the use of OK lenses worldwide, potential complications have become a major concern for parents. Potential complications include keratitis and corneal epithelial damage. In addition, overnight OK lens wear has been associated with decreased tear production and reduced tear film stability. Recently, a four-week study by Carracedo et al. demonstrated that OK lens wear did not significantly change fluorescein-stained tear film breakup time or Schirmer's test I results, but subjects had increased dry eye symptoms one month after wear Decrease in cupped cell density.

Diquafosol Ophthalmic Solution (DQS) is a potent purinergic P2Y2 receptor agonist, a stabilized synthetic derivative of the naturally-occurring nucleotide uridine 5'-triphosphate; it stimulates the secretion of mucin and tears by conjunctival cup cells and conjunctival epithelial cells. Several studies have shown that Diquafosol sodium is effective in the treatment of dry eye. In addition, some studies have shown that Diquafosol sodium eye drops have significantly alleviated dry eye symptoms and improved ocular surface parameters in children wearing keratomileusis lenses at night. However, the available research lacks the ability of the DQS to assess the effect of DQS on visual acuity and quality of life improvement in patients with dry eye after wearing OK lenses. The results would inform clinicians to improve comfort and compliance with keratoplasty lenses in adolescents.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 8-18 years old
  • Wearing corneal shape mirror more than one year and at least eight hours every night
  • Myopia -5.50 to -1.00 D, astigmatism < 1.75 D, or curvature between 41.00 and 46.00D, astigmatism < -0.75D, and best corrected visual acuity ≥1.0.
  • Diagnosis of dry eye: patients complained of dry eye, foreign body sensation, burning sensation, fatigue, discomfort, envy, subjective symptom such as vision fluctuation; (a) OSDI questionnaire score >13 points, and (b) NITBUT <10 s or (c) ocular surface dyeing assessment > 5 corneal spots/more than nine conjunctival spots.
  • Participants were able to use eye drops as required, complete examinations, and return to the hospital for follow-up examinations within the specified time to complete follow-up.

Exclusion Criteria:

  • Suffering from allergic or autoimmune disease associated with dry eye of the participants are not suitable for wearing OK lens
  • Pathological changes in the corneal rim
  • Eyelid rim lesions, cornea, uveitis, retina and other systemic diseases may affect the ocular surface. Examples include severe ocular surface diseases (Sjögren's syndrome, allergic conjunctivitis, ocular papules, conjunctival chafing, conjunctival scarring, and chemical damage);
  • Received any dry eye treatment within 14 days prior to the start of this study or continued use of other topical eye drops that would affect the results of the study.
  • Have received any other eye treatment or surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DQS group
Participants in DQS group will be administered one drop of 3% DQS (Diquas, Santen Pharmaceutical Co.,Ltd., Osaka, Japan) six times per day for 4 weeks
Drug: 3% Diquafosol tetrasodium
3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in OK lens related dry eye
Other Names:
  • Diquas

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pediatric Refractive Error Profile(PREP) questionnaire score
Time Frame: Day-0 (baseline), 2-weeks, 4-weeks
Specifically to assess children's vision related quality of life, a total of 26 problem, original score for each from 5 points (positive) to 1 (negative), and then the original score for each minus 1 multiplied by 25, from 100 points (life quality) to 0 rating (poor quality of life), the average score for all 26 PREP problem of. "Strongly disagree" corresponds to 5 points when the statement is reversed.
Day-0 (baseline), 2-weeks, 4-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-invasive tear break-up time
Time Frame: Day-0 (baseline), 2-weeks, 4-weeks
Changes in non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.
Day-0 (baseline), 2-weeks, 4-weeks
Tear Film Lipid Layer
Time Frame: Day-0 (baseline), 2-weeks, 4-weeks
Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan).
Day-0 (baseline), 2-weeks, 4-weeks
Tear meniscus height
Time Frame: Day-0 (baseline), 2-weeks, 4-weeks
Changes in TMH will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.
Day-0 (baseline), 2-weeks, 4-weeks
Ocular Surface Disease Index(OSDI) questionnaire score
Time Frame: Day-0 (baseline), 2-weeks, 4-weeks
the Chinese language-validated OSDI, which is a questionnaire consisting of 12 questions for evaluating the effects of dry eye syndrome on vision, ocular symptoms, and any condition associated with DED, will be used. Te patient will answer each question on a scale ranging from 0 to 4, with 0 indicating "none of the time" and 4 indicating "all of the time." If a certain question is deemed irrelevant, it will be marked as "not applicable (N/A)" and excluded from the analysis. The OSDI total score is calculated according to the proprietary formula proposed by the authors of the original OSDI. The scale ranges from 0 to 100, with higher scores representing more severe cases of DED.
Day-0 (baseline), 2-weeks, 4-weeks
Objective visual quality assessment
Time Frame: Day-0 (baseline), 2-weeks, 4-weeks
Using SCHWIND SIRIUS eyes analyzer objective visual quality assessment, including: total higher-order aberrations, spherical aberration, coma makes, clover, and RMS values etc..
Day-0 (baseline), 2-weeks, 4-weeks
Conjunctivocorneal staining grade
Time Frame: Day-0 (baseline), 2-weeks, 4-weeks
Using fluorescein sodium solution or fluorescein sodium test paper to contact the lower eyelid margin, corneal and conjunctival epithelial defects under the cobalt blue light of the slit lamp microscope showed different morphology, such as green spots, erosion, lamellar defects, ulcers and so on. The following categories: according to the severity of the symptoms can be mild, slit lamp microscope check no obvious signs of ocular surface damage (corneal fluorescein staining point < 5); Moderate: the extent of corneal damage under the slit lamp microscope did not exceed 2 quadrants and (or) the number of corneal fluorescein staining spots was >5 and <30. Severe: the range of corneal damage was 2 quadrants or more and (or) the corneal fluorescent staining spots were more than 30. The fluorescein staining spots in the cornea fused into thick spots, sheets or with filaments.
Day-0 (baseline), 2-weeks, 4-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 15, 2024

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 1, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DQS2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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