Managing Dry Eye in Patients Using Glaucoma Drops

December 25, 2023 updated by: He Eye Hospital
A single center randomized controlled trial on managing dry eye signs and symptoms in patients using anti-glaucoma eye drops.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To compare the safety and efficacy of IPL therapy on drug-induced dry eye caused by long-term use of anti glaucoma drugs;

Study Type

Interventional

Enrollment (Actual)

60

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

Study Contact Backup

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • He Eye Hospital
        • Sub-Investigator:
          • Qing Zhang, M.D.
        • Sub-Investigator:
          • Hongda Zhang, M.D.
        • Contact:
        • 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥18 years
  • Able and willing to comply with the treatment/follow-up schedule
  • Bilateral signs and symptoms of dry eye disease

Exclusion Criteria:

  • Participants with systemic immune-mediated illnesses, such as secondary Sjögren's syndrome or graft-versus-host disease
  • Patients using topical medication(s) for the treatment of ocular disorders such as allergic conjunctivitis were excluded from the study.
  • Previous ocular surgery or trauma
  • 1-month history of blepharal and periorbital skin disease or allergies
  • Severe dry eyes with corneal epithelial defect
  • Limbic keratitis
  • Pterygium
  • Corneal neovascularization
  • Breastfeeding
  • Rheumatic immune systemic diseases
  • Herpes zoster infection
  • Pregnant women
  • Allergic to fluorescein
  • Contact lens wearers

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IPL group
IPL group will use 2 sessions of IPL therapy, 15 days apart for the management of drug-induced dry eye in glaucoma patients.
Device: IPL
Intense pulse light (IPL) therapy is used for the treatment of drug-related dry eye in glaucoma patients.
Other Names:
  • Intense pulsed light
No Intervention: Control group
The control group received no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-invasive tear break-up time
Time Frame: Day-0 (baseline), 2-week, 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-week, 4-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conjunctival hyperemia (RS score)
Time Frame: Day-0 (baseline), 2-week, 4-weeks
Conjunctival hyperemia (RS score) will be assessed by keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 to 4.0.
Day-0 (baseline), 2-week, 4-weeks
Quality of meibum grade
Time Frame: Day-0 (baseline), 2-week, 4-weeks

Meibum quality will be assessed under a slit-lamp:

Five meibomian gland in the middle parts of the eyelid will be assessed using a scale of 0 to 3 for each gland (0 represented clear meibum; 1 represented cloudy meibum; 2 represented cloudy and granular meibum; and 3 represented thick, toothpaste like consistency meibum).
Day-0 (baseline), 2-week, 4-weeks
Expressibility of meibum grade
Time Frame: Day-0 (baseline), 2-week, 4-weeks

Meibum expressibility will be assessed under a slit-lamp:

Eight meibomian glands in the middle part will be evaluated on a scale of 0 to 3 (0 denoted that all glands expressible; 1 denoted that 3 to 4 glands expressible; 2 denoted those 1 to 2 glands expressible; and 3 denoted that no glands were expressible). The overall score was computed using the mean scores of these eight glands.
Day-0 (baseline), 2-week, 4-weeks
Conjunctivocorneal epithelial staining grade
Time Frame: Day-0 (baseline), 1-week, 2-weeks

Conjunctivocorneal epithelial staining will be assessed under a slit-lamp:

Conjunctivocorneal epithelial staining will be assess corneal and conjunctival epithelium damage. Double vital staining approach with two microliters of a preservative-free solution containing 1% lissamine green and 1% sodium fluorescein will be instilled in the conjunctival sac.

The eye will be sectioned into three equal pieces (temporal conjunctiva, cornea, and nasal conjunctiva). Each region receives a maximum staining score of three points and a minimum of zero points. The combined scores from all three parts were then recorded on a scale ranging from 0 (normal) to 9 (severe).
Day-0 (baseline), 1-week, 2-weeks
Tear Film Lipid Layer
Time Frame: Day-0 (baseline), 2-week, 4-weeks
Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan).
Day-0 (baseline), 2-week, 4-weeks
OSDI Score
Time Frame: Day-0 (baseline), 2-week, 4-weeks
Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will beused to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points
Day-0 (baseline), 2-week, 4-weeks

Collaborators and Investigators

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

Sponsor

He Eye Hospital

Investigators

  • Study Chair: Emmanuel Eric Pazo, He Eye Hospital, Shenyang, China

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 (Actual)

October 3, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 2, 2023

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 25, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GLADQSLIP2023

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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