Comparing the after-use sensation and safety of long acting (LA) carteolol 2 % versus timolol LA 0.5 % in simple intra-ocular hypertension and glaucoma
- Conditions
- nilateral or bilateral ocular hypertensionPrimary Open Angle Glaucoma (POAG)Eye DiseasesGlaucoma
- Registration Number
- ISRCTN31673586
- Lead Sponsor
- Dr. Mann Pharma GmbH, Bausch & Lomb Inc. (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 194
1. Adult patients, men or women
2. Suffering from unilateral or bilateral ocular hypertension or POAG
3. Intraocular Pressure (IOP) controlled with beta-blocker monotherapy (IOP < 21mmHg and
visual field stable)
4. Written informed consent
1. Age < 18 years
2. IOP not controlled with beta-blocker monotherapy
3. Angle closure, congenital and secondary glaucoma
4. Any pathology contraindicating an IOP measurement
5. Any intraocular infection or inflammation, ocular trauma, ocular surgery or laser trabeculoplasty within the previous 3 months
6. Previous intolerance to carteolol or timolol, or to any other ingredients of
the tested products
7. Beta-blocker contraindications
8. Ocular corticosteroids
9. Contact lens wearers
10. Severe systemic or ocular disease
11. Hypotension
12. Drug, alcohol abuse
13. Involvement in the last 30 days in any other investigational drug study
14. Expected change in treatment of concomitant disease
15. Patients with a history of recurrent ocular herpes and/or recurrent uveitis
16. Change in ocular treatment within the last month
17. Patients treated with other topical ocular treatment within the last month
18. Pregnant or lactating women
19. Women of child-bearing potential considering becoming pregnant during the course of the study and those not taking precautions to avoid pregnancy
20. Patients for whom, in the physician's opinion, any of the protocol
procedures may pose a special risk not outweighed by the potential benefits of participating in the study
21. Patients who are unlikely to comply with the study protocol or who are likely to be moving and lost to follow up in the study period
22. Patients with neurotic, psychiatric disorders or suicidal tendencies
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluation of the subjective tolerance upon instillation (rate of patients experiencing symptoms of discomfort), graded as very good, good, bad or very bad, measured at baseline, 1 and 3 months
- Secondary Outcome Measures
Name Time Method