Ocular Surface Disease in Glaucoma Patients on Long-Term Therapy

September 24, 2026 updated by: Margo Mahrous Fawzy Awad, Assiut University

Prevalence and Severity of Ocular Surface Disease Among Adult Patients With Glaucoma on Long-Term Topical Antiglaucoma Medications

This cross-sectional study aims to determine the prevalence and severity of ocular surface disease among adult patients with glaucoma receiving long-term topical antiglaucoma medications.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Long-term use of topical antiglaucoma medications may adversely affect the ocular surface. This observational study will include adult patients with glaucoma who have been using one or more topical antiglaucoma medications for at least 6 months.

Participants will complete the Ocular Surface Disease Index (OSDI) questionnaire and undergo clinical ocular surface assessment including tear film break-up time, Schirmer I test, and corneal fluorescein staining.

Study Type

Observational

Enrollment (Estimated)

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

Name: Margo f Awad, Resident
Phone Number: +20 12 73302611
Email: margo19.mahros@gmail.com

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with diagnosed glaucoma receiving long-term topical antiglaucoma medications at Assiut University Hospital and El Mabarra Hospital.

Description

Inclusion Criteria:

- Age 18 years or older
Diagnosed glaucoma
Currently receiving one or more topical antiglaucoma medications
Duration of topical antiglaucoma treatment ≥6 months
Written informed consent

Exclusion Criteria:

- Current use of concomitant topical ocular medication that may affect the ocular surface (e.g., topical cyclosporine)
Previous ocular surgery within the preceding 6 months
History of corneal surgery or significant ocular trauma affecting the ocular surface
Active ocular infection or significant active ocular inflammation
Contact lens wear
Systemic autoimmune or connective tissue diseases known to affect the ocular surface (e.g., Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus)
Significant corneal pathology interfering with ocular surface assessment

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

Observational Models: CASE_ONLY
Time Perspectives: CROSS_SECTIONAL

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Single cohort: Glaucoma patients on long-term topical therapy Adult patients with glaucoma receiving topical antiglaucoma medications for at least 6 months who will undergo OSDI questionnaire and clinical ocular surface assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of ocular surface disease Time Frame: Baseline	Proportion of patients with ocular surface disease defined as an Ocular Surface Disease Index (OSDI) score ≥13.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients with Mild Ocular Surface Disease Symptoms Time Frame: Baseline	Proportion of patients with mild ocular surface disease symptoms defined as OSDI score 13-22.	Baseline
Proportion of Patients with Moderate Ocular Surface Disease Symptoms Time Frame: Baseline	Proportion of patients with moderate ocular surface disease symptoms defined as OSDI score 23-32.	Baseline
Proportion of Patients with Severe Ocular Surface Disease Symptoms Time Frame: Baseline	Proportion of patients with severe ocular surface disease symptoms defined as OSDI score 33-100.	Baseline
Mean OSDI score Time Frame: Baseline	Mean Ocular Surface Disease Index score (range 0-100).	Baseline
Tear film break-up time (TBUT) Time Frame: Baseline	Mean tear film break-up time in seconds.	Baseline
Schirmer I test result Time Frame: Baseline	Mean Schirmer I test value in millimeters.	Baseline
Corneal fluorescein staining score Time Frame: Baseline	Mean total corneal fluorescein staining score (range 0-15) according to the NEI/Industry Workshop grading scale.	Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

Study Chair: Mohamed s Abdel-rehim, prof, Ophthalmology Department, Assiut University Hospitals

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)

September 26, 2026

Primary Completion (Estimated)

September 26, 2027

Study Completion (Estimated)

April 20, 2028

Study Registration Dates

First Submitted

September 20, 2026

First Submitted That Met QC Criteria