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Not yet recruitingNCT07841912Updated Sep 28, 2026

Ocular Surface Disease in Glaucoma Patients on Long-Term Therapy

An observational study in Glaucoma, Ocular Surface Disease and Dry Eye, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Assiut University · Observational

Updated Sep 25, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
55
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Glaucoma
  • Ocular Surface Disease
  • Dry Eye

Keywords

  • Ocular surface disease
  • Glaucoma
  • OSDI
  • Topical antiglaucoma medications
  • Assiut
03

In context

Glaucoma

1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.

This study's planned enrollment of 55 is below the median of 101 across 385 observational studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion criteria

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
55 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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.

    Time frame: Baseline

Secondary outcomes

  1. Proportion of Patients with Mild Ocular Surface Disease Symptoms

    Proportion of patients with mild ocular surface disease symptoms defined as OSDI score 13-22.

    Time frame: Baseline

  2. Proportion of Patients with Moderate Ocular Surface Disease Symptoms

    Proportion of patients with moderate ocular surface disease symptoms defined as OSDI score 23-32.

    Time frame: Baseline

  3. Proportion of Patients with Severe Ocular Surface Disease Symptoms

    Proportion of patients with severe ocular surface disease symptoms defined as OSDI score 33-100.

    Time frame: Baseline

  4. Mean OSDI score

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

    Time frame: Baseline

  5. Tear film break-up time (TBUT)

    Mean tear film break-up time in seconds.

    Time frame: Baseline

  6. Schirmer I test result

    Mean Schirmer I test value in millimeters.

    Time frame: Baseline

  7. Corneal fluorescein staining score

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

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 20, 2026
First posted
Sep 25, 2026
StartEst.
Sep 26, 2026
Primary completionEst.
Sep 26, 2027
CompletionEst.
Apr 20, 2028
Last update
Sep 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Sep 25, 2026
Show all 2 updates
  1. Sep 28, 2026
    Minor edits only
    + 1 other change: responsible party
  2. Sep 25, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07841912
Lead sponsor
Assiut University
Responsible party
Margo Mahrous Fawzy Awad (Principal Investigator, Assiut University) — Principal investigator
First posted
Sep 25, 2026
Start date
Sep 26, 2026 (estimated)
Primary completion
Sep 26, 2027 (estimated)
Completion
Apr 20, 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Margo f Awad, Resident
Contact
margo19.mahros@gmail.com
+20 12 73302611
Mohamed s Abdel-rehim, prof
study chair · Ophthalmology Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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