NCT07841912

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
19mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Apr 2028

First Submitted

Initial submission to the registry

September 20, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 26, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2028

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 20, 2026

Last Update Submit

September 24, 2026

Conditions

Keywords

Ocular surface diseaseGlaucomaOSDITopical antiglaucoma medicationsAssiut

Outcome Measures

Primary Outcomes (1)

  • Prevalence of ocular surface disease

    Proportion of patients with ocular surface disease defined as an Ocular Surface Disease Index (OSDI) score ≥13.

    Baseline

Secondary Outcomes (7)

  • Proportion of Patients with Mild Ocular Surface Disease Symptoms

    Baseline

  • Proportion of Patients with Moderate Ocular Surface Disease Symptoms

    Baseline

  • Proportion of Patients with Severe Ocular Surface Disease Symptoms

    Baseline

  • Mean OSDI score

    Baseline

  • Tear film break-up time (TBUT)

    Baseline

  • +2 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

GlaucomaDry Eye Syndromes

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesLacrimal Apparatus Diseases

Study Officials

  • Mohamed s Abdel-rehim, prof

    Ophthalmology Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Margo f Awad, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 20, 2026

First Posted

September 25, 2026

Study Start

September 26, 2026

Primary Completion (Estimated)

September 26, 2027

Study Completion (Estimated)

April 20, 2028

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share