Open angle glaucoma or ocular hypertension MedDRA version: 9.1 Level: LLT Classification code 10030348 Term: Open angle glaucoma
Conditions
Interventions
Product Name: Dorzolamide 2% eye drops solution
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: DORZOLAMIDE HYDROCHLORIDE
CAS Number: 130693-82-2
Concentration unit: mg/ml milligram(s)/m
Sponsors
ALFRED E. TIEFENBACHER (GMBH & CO. KG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria: Subjects meeting all of the following criteria will be considered for enrolment to the trial: • Male or female patients of any race aged 18 years or older • A clinical diagnosis of open angle glaucoma, pseudoexfoliation or pigment dispersion glaucoma, or ocular hypertension in one or both eyes • IOP controllable on one drug treatment in the study eye(s) in a way that assures clinical stability of vision and the optic nerve throughout the study • Baseline IOP between 18 and 32 mmHg in the study eye(s) (in eyes not included in the study IOP must have been controllable on no pharmacologic treatment or on the study medicine only) • Best corrected visual acuity of 20/200 or better in the study eye(s) 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: Main exclusion criteria: Subjects presenting 1 of the following criteria will not be enrolled in the trial: • Chronic or recurrent inflammatory eye disease • Ocular trauma within the past six months • Current ocular infection, i.e. conjunctivitis or keratitis • Any abnormality preventing reliable applanation tonometry • Intraocular surgery or laser treatment within the past three months • Inability to discontinue contact lens wear during the study • Use of any systemic medication that would affect IOP with less than a 1-month stable dosing regimen before the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the equivalence of topically administered Dorzolamide 2% Eye Drops Solution (test formulation) compared to Trusopt® Eye Drops Solution (reference formulation) in lowering intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension;Secondary Objective: To assess the safety and tolerability of repeated topical administration of Dorzolamide 2% eye drops solution in subjects with open angle glaucoma or ocular hypertension;Primary end point(s): The primary efficacy parameter will be the difference in mean diurnal IOP from visit 1 (baseline) to visit 2 and from visit 3 (baseline) to visit 4: dIOPav=IOPav baseline - IOPav dorzolamide | — |
Countries
Germany
Outcome results
None listed