Open-angle glaucoma and ocular hypertension
Conditions
Interventions
Product Name: Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution
Pharmaceutical Form: Eye drops, solution
INN or Proposed INN: Travoprost
CAS Number: 157283-68-6
Current Sponsor code: AL-6221
Concentr
Sponsors
Alcon Research, Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Male or female patients 18 years of age or older diagnosed with open-angle glaucoma or ocular hypertension who are currently on one or more IOP-lowering medications and, in the opinion of the investigator, would benefit from one of the combination therapies. •Patients must meet the following IOP entry criteria in at least one treated eye: (1) For the qualifying treated eye(s), the mean IOP must be greater or equal to 24 mmHG at 9 AM and 21 mmHG at 4 PM on the Eligibility Visits 1 and 2, (2) The mean IOP in either eye must not be greater than 36 mmHg at any time point, (3) The same eye(s) must qualify at both time points at the Eligibility Visits 1 and 2. •Patients must be able to discontinue use of all IOP-lowering medication(s) for a minimum period of 5 days ± 1 day, to 28 days ± 1 day prior to the Eligibility Visit 1. •Only patients who satisfy all informed consent requirements may be included in the study. 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: •Females of childbearing potential (those who are not surgically sterilized at least 3 months prior to study start or who are at least two years post-menopausal) if they are pregnant or breast-feeding or not using highly effective birth control measures. •Patients with any form of glaucoma other than open-angle glaucoma or ocular hypertension. •Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to the Eligibility 1 Visit. •History of chronic recurrent, or current severe inflammatory eye disease (i.e., scleritis, uveitis, herpes keratitis) in either eye. •History of, or current other severe ocular pathology (including severe dry eye) in either eye or serious hypersensitivity to prostaglandin drugs or their analoques, that would preclude the administration of a topical prostaglandin analogue, carbonic anhydrase inhibitor, or beta-blocker. •Patients who cannot safely discontinue their glucocorticoid medications administered by any route. •History of spontaneous or current hypoglycaemia or uncontrolled diabetes. •Any abnormality preventing reliable applanation tonometry of either eye. •History of, or current clinically relevant or progressive retinal disease. •History of intraocular trauma or surgery within the past six months. •Patients with less than 30 days stable dosing regimen before the Screening Visit of any non-glaucoma medications. •History of, or current bronchial asthma, severe chronic obstructive pulmonary disease, or severe unstable or uncontrolled cardiovascular, hepatic or renal disease. •Patients with best-corrected visual acuity worse than 0.6 logMAR score in either eye. •Patients with angle grade less than Grade 2 measured by gonioscopy. •Patients with a cup/disc ratio greater than 0.80 in either eye. •Additionally, the Medical Monitor may declare any patient ineligible for a valid medical reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to compare the IOP-lowering efficacy and safety of dosing of Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution (once-daily morning dosing) vs. Dorzolamide 2%/Timolol 0.5% Ophthalmic Solution, dosed twice-daily, in patients with open-angle glaucoma or ocular hypertension.;Secondary Objective: ;Primary end point(s): The primary statistical objective of this study is to demonstrate that the IOP-lowering efficacy of dosing Travoprost 0.004%/Timolol 0.5% Ophthalmic Solution (once-daily morning dosing) is superior to Dorzolamide 2%/Timolol 0.5% Ophthalmic Solution, dosed twice-daily. | — |
Countries
Germany, Hungary, Italy, Latvia, Spain, United Kingdom
Outcome results
None listed