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.
- Conditions
- MedDRA version: 12.1Level: LLTClassification code 10018304Term: GlaucomaGlaucoma or ocular hypertensionMedDRA version: 12.1Level: LLTClassification code 10030043Term: Ocular hypertension
- Registration Number
- EUCTR2010-023627-14-FI
- Lead Sponsor
- Santen Oy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 880
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method