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NCT Number: NCT07841912

Ocular Surface Disease in Glaucoma Patients on Long-Term Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Mean OSDI score

    Time frame: Baseline

    Mean Ocular Surface Disease Index score (range 0-100).

  5. Tear film break-up time (TBUT)

    Time frame: Baseline

    Mean tear film break-up time in seconds.

  6. Schirmer I test result

    Time frame: Baseline

    Mean Schirmer I test value in millimeters.

  7. Corneal fluorescein staining score

    Time frame: Baseline

    Mean total corneal fluorescein staining score (range 0-15) according to the NEI/Industry Workshop grading scale.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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