GlaucomaNCT07841912
Ocular Surface Disease in Glaucoma Patients on Long-Term Therapy
An observational study of Glaucoma and Ocular Surface Disease, run by Assiut University.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Surface Disease, Dry Eye
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2026to 20 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with diagnosed glaucoma receiving long-term topical antiglaucoma medications at Assiut University Hospital and El Mabarra Hospital.
Who may be able to join
- - 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
Who cannot join
- - 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
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.
- Conditions
- Glaucoma, Ocular Surface Disease, Dry Eye
- Keywords
- Ocular surface disease, Glaucoma, OSDI, Topical antiglaucoma medications, Assiut
- Medical subject headings
- Glaucoma, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of ocular surface disease
Proportion of patients with ocular surface disease defined as an Ocular Surface Disease Index (OSDI) score ≥13.
Measured: Baseline
Secondary outcomes (7)
Proportion of Patients with Mild Ocular Surface Disease Symptoms
Proportion of patients with mild ocular surface disease symptoms defined as OSDI score 13-22.
Measured: Baseline
Proportion of Patients with Moderate Ocular Surface Disease Symptoms
Proportion of patients with moderate ocular surface disease symptoms defined as OSDI score 23-32.
Measured: Baseline
Proportion of Patients with Severe Ocular Surface Disease Symptoms
Proportion of patients with severe ocular surface disease symptoms defined as OSDI score 33-100.
Measured: Baseline
Mean OSDI score
Mean Ocular Surface Disease Index score (range 0-100).
Measured: Baseline
Tear film break-up time (TBUT)
Mean tear film break-up time in seconds.
Measured: Baseline
Schirmer I test result
Mean Schirmer I test value in millimeters.
Measured: Baseline
Corneal fluorescein staining score
Mean total corneal fluorescein staining score (range 0-15) according to the NEI/Industry Workshop grading scale.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start26 Sep 2026 (estimated)
- Primary completion26 Sep 2027 (estimated)
- Study completion20 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margo Mahrous Fawzy Awad, Assiut University
- Investigators
- Mohamed s Abdel-rehim, prof, Study chair, Ophthalmology Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07841912
- Sponsor's protocol ID
- OSD-Glaucoma-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Severity of Ocular Surface Disease Among Adult Patients With Glaucoma on Long-Term Topical Antiglaucoma Medications
- ClinicalTrials.gov ID
- NCT07841912
- Acronym / sponsor ID
- OSD-Glaucoma-Assiut-2026
- Conditions
- Glaucoma, Ocular Surface Disease, Dry Eye
- Keywords
- Ocular surface disease, Glaucoma, OSDI, Topical antiglaucoma medications, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Sep 2026 (estimated)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 20 Apr 2028 (estimated)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diagnosed glaucoma receiving long-term topical antiglaucoma medications at Assiut University Hospital and El Mabarra Hospital.
Key inclusion criteria (5 listed)
- - 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
Key exclusion criteria (7 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Proportion of Patients with Mild Ocular Surface Disease Symptoms
Time frame: Baseline
Proportion of Patients with Moderate Ocular Surface Disease Symptoms
Time frame: Baseline
Proportion of Patients with Severe Ocular Surface Disease Symptoms
Time frame: Baseline
Mean OSDI score
Time frame: Baseline
Tear film break-up time (TBUT)
Time frame: Baseline
Schirmer I test result
Time frame: Baseline
Corneal fluorescein staining score
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed s Abdel-rehim, prof study chair
Ophthalmology Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Ocular Surface Disease, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margo f Awad, Resident (+20 12 73302611, margo19.mahros@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of ocular surface disease (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.