Adult patients suffering from unilateral or bilateral ocular hypertension or POAG, IOP controlled with beta-blocker monotherapy (IOP < 21 mmHg and visual field stable)
Conditions
Interventions
Trade Name: Carteol LP 2%, collyre en solution à libération prolongée
Product Name: carteolol LA 2%
Pharmaceutical Form: Eye drops, prolonged-release
INN or Proposed INN: carteolol Hydrochloride
CAS N
Sponsors
Bausch&Lomb Dr Gerhard Mann chem.-Fabrik GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult patients, men or women • Suffering from unilateral or bilateral ocular hypertension or POAG • IOP controlled with beta-blocker monotherapy (IOP =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Age < 18 years • IOP not controlled with beta-blocker monotherapy • Angle closure, congenital and secondary glaucoma • Any pathology contraindicating an IOP measurement • Any intraocular infection or inflammation, ocular trauma, ocular surgery or laser trabeculoplasty within the previous 3 months • Previous intolerance to carteolol or timolol, or to any other ingredients of the tested products • Beta-blocker contraindications • Ocular corticosteroids • Contact lens wearers • Severe systemic or ocular disease • Hypotension • Drug, alcohol abuse • Involvement in the last 30 days in any other investigational drug study • Expected change in treatment of concomitant disease • Patients with a history of recurrent ocular herpes and/or recurrent uveitis. • Change in ocular treatment within the last month. • Patients treated with other topical ocular treatment within the last month • Pregnant or lactating women. • Women of child-bearing potential considering becoming pregnant during the course of the study and those not taking precautions to avoid pregnancy. • 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. • 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. • Patients with neurotic, psychiatric disorders or suicidal tendencies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To evaluate the subjective tolerance upon instillation (rate of patients experiencing symptoms of discomfort ) of carteolol LA compared to timolol LA in patients with simple ocular hypertension or POAG (superiority design);Secondary Objective: • 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) • Subjective tolerance upon isntillation graded as very good/good/bad/very bad • External and Slit lamp examination • Break up time • Fluorescein test • Lissamine green test. • IOP measured at 12 PM (+/- 30mn) • Visual acuity • Visual field • Fundoscopy • Adverse events • Compliance ;Primary end point(s): Safety : Primary variable : • Rate of patients experiencing discomfort upon instillation after 3 months of treatment | — |
Countries
Belgium, Czech Republic, France, Portugal
Outcome results
None listed