Cross-sectional study to investigate the occurence and severity of signs and symptoms of ocular surface disease in patients with ongoing chronic topical treatment for glaucoma or ocular hypertension.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023627-14-FI

Enrollment

880

Registered

2010-12-08

Start date

2011-02-09

Completion date

Unknown

Last updated

2012-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma or ocular hypertension MedDRA version: 12.1 Level: LLT Classification code 10030043 Term: Ocular hypertension MedDRA version: 12.1 Level: LLT Classification code 10018304 Term: Glaucoma

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients of any race and either sex meeting all of the following criteria will be considered eligible for this study: Glaucoma patients: 1. Aged 18 years or more 2. Diagnosis of glaucoma/OH: primary open angle glaucoma, pseudoexfoliation glaucoma, pigmentary glaucoma, ocular hypertension (being treated) 3. Are willing to follow instructions 4. Have provided a written informed consent Control patients (equal number of males and females at each center): 1. Aged 40 years or older 2. No prior or current use of ocular hypertensive medications 3. Willing to follow instructions 4. Have provided written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Current participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days 2. Eye surgery performed within the last 6 months 3. Patients with known or seasonal allergy 4. Known alcoholism, or other drug abuse that could influence the variables to be studied

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the occurrence and severity of signs and symptoms of ocular surface disease in patients having ongoing chronic topical treatment for glaucoma or OH.;Secondary Objective: To correlate the findings to the type of treatment and exposure of the eye to BAC in the ophthalmic formulations used. To investigate the concordance between findings in made in ophthalmologist’s examination and symptoms reported by the patients.;Primary end point(s): • Occurrence and severity of ocular signs and symptoms • Comparison of variables to control patient group • Relationship between use of BAC (in eye drops) and ocular signs and symptoms • Concordance between findings made by ophthalmologist and symptoms reported to a nurse by the patients	—

Measure

Time frame

Main Objective: To investigate the occurrence and severity of signs and symptoms of ocular surface disease in patients having ongoing chronic topical treatment for glaucoma or OH.;Secondary Objective: To correlate the findings to the type of treatment and exposure of the eye to BAC in the ophthalmic formulations used. To investigate the concordance between findings in made in ophthalmologist’s examination and symptoms reported by the patients.;Primary end point(s): • Occurrence and severity of ocular signs and symptoms • Comparison of variables to control patient group • Relationship between use of BAC (in eye drops) and ocular signs and symptoms • Concordance between findings made by ophthalmologist and symptoms reported to a nurse by the patients

—

Countries

Finland

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026