Unilateral or bilateral ocular hypertension
Conditions
Interventions
Written informed consent was obtained at baseline visit 1 (day 0). Eligibility was determined by reviewing medical history, recording of concomitant medication, external eye examination (signs of infl
Sponsors
Dr. Mann Pharma GmbH, Bausch & Lomb Inc. (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Assessment of each of the symptoms of the Glaucoma Symptom Scale [15] (Yes/ No): burning/smarting/stinging, tearing, dryness, itching, soreness/tiredness, feeling of something in the eye, blurry/dim vision, hard to see in daylight, hard to see in dark places and halos around the light (for those who report a given symptom, a bothersome scale will be used: very, somewhat, a little, not at all) 2. Slit lamp examination (examination of conjunctiva, cornea, iris, lens, anterior chamber), performed at baseline, 1 and 3 months 3. Tear-film-break-up-time-test (BUT-test; sec), performed at baseline, 1 and 3 months 4. Fluorescein staining of the cornea, performed at baseline, 1 and 3 months 5. Van Bijsterveld test (Lissamine green), performed at baseline, 1 and 3 months 6. IOP measured at 12 PM (+/- 30mn), measured at baseline, 1 and 3 months 7. Assessment of Visual acuity and visual field, measured at baseline (if no visual field performed during the previous 3 months) and at 3 months 8. Fundoscopy, performed at baseline, 1 and 3 months 9. Adverse events, reported at 1 and 3 months 10. Compliance, reported at 1 and 3 months | — |
Countries
Belgium, Czech Republic, France, Poland, Portugal
Outcome results
None listed