primary open-angle glaucoma ocular hypertension pigment dispersion glaucoma MedDRA version: 8.1 Level: LLT Classification code 10036719 Term: Primary open angle glaucoma
Conditions
Interventions
Trade Name: DuoTrav
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: travoprost
Concentration unit: µg/ml microgram(s)/millilitre
Concentration type: equal
Concentration number: 40-
INN o
Sponsors
Alcon Laboratories, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Must be at least 18 years of age. Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in at least one eye (study eye). Must have been treated with mono- or adjunctive therapy (in a fixed or unfixed combination) for a minimum of one week at Visit 1. Also, the last dose of the previous medicine must have been instilled correctly so the patient is within the dosing cycle at Visit 1. Have an intraocular pressure of between 19 and 35 mm Hg inclusive in at least one eye and = 35 mm Hg in both eyes on monotherapy or between 19 and 32 mm Hg inclusive in at least one eye and = 32 mm Hg in both eyes on two-drug therapy at Visit 1. Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye. 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: Presence of other primary or secondary glaucomas not listed in inclusion criterion. Presence of extreme narrow angle with complete or partial closure in either eye, as measured by gonioscopy (occludable angles treated with a patent iridectomy are acceptable). Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed. Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to Visit 1. Women of childbearing potential not using reliable means of birth control Women who are pregnant or lactating Known medical history of allergy, sensitivity or poor tolerance to any components of the preparations to be used in this trial that is deemed clinically significant in the opinion of the Principal Investigator. Use of systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Visit 1 or an anticipated change in the dosage during the course of the study. History of bronchial asthma, chronic obstructive pulmonary disease, decompensated heart failure, or second- or third-degree heart block that would preclude the safe administration of a topical beta-blocker. Unwillingness to risk the possibility of darkened irides or eyelash changes A history of, or at risk for uveitis or cystoid macular edema (CME). History of ocular herpes simplex. Sinus bradycardia (< 50 beats per minute). Corneal dystropies. Severe allergic rhinitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and efficacy of switching to DuoTrav from other mono- or adjunctive (fixed or unfixed combinations) therapies;Secondary Objective: ;Primary end point(s): The mean intraocular pressure at the final visit (Month 3, Visit 3) of patients switched to DuoTrav at enrollment (Day 0, Visit 1) from travoprost. | — |
Countries
Germany
Outcome results
None listed