Assessing the Efficacy of DuoTrav as a Replacement Therapy in Glaucoma Patients in Russia

Assessing the Efficacy of DuoTrav® (Travoprost 0.004%/Timolol 0.5% Fixed Combination), as a Replacement Therapy in Glaucoma Patients in Russia, Previously on Prior Prostaglandin Analogue or Beta-blocker Monotherapy

The purpose of this study is to evaluate the efficacy of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5%) from prior prostaglandin analogue or beta-blocker monotherapy in Russian glaucoma patients with open-angle glaucoma or ocular hypertension whose intraocular pressure (IOP) is uncontrolled while on their current treatment.

Study Overview

• Status: Withdrawn
• Conditions: Ocular Hypertension; Glaucoma
• Intervention / Treatment: Drug: Travoprost 0.004%/Timolol 0.5% Fixed Combination (DuoTrav)

• Study Type: Interventional
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of ocular hypertension, primary open-angle glaucoma and pseudoexfoliative or pigment dispersion glaucoma.
• Be on a stable IOP-lowering regimen of prostaglandin analogue or beta-blocker (monotherapy) within 4 weeks prior to the Screening Visit.
• Have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
• Have an IOP of between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye). In any eye not designated as a study eye, the IOP should be able to be controlled on no pharmacologic therapy or on the study medicine alone.
• Willing to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.
• Able to follow instructions and willing and able to attend all study visits.
• Have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
• Read, sign, and date an Ethics Committee reviewed and approved informed consent form.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known medical history of allergy, hypersensitivity or poor tolerance to any component of DuoTrav® that is deemed clinically significant in the opinion of the Principal Investigator.
• Any abnormality preventing reliable applanation tonometry in either eye.
• Corneal dystrophies in either eye.
• Any opacity or subject uncooperativeness that restricts adequate examination of the anterior chamber of either eye.
• Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
• History of ocular herpes simplex infection.
• Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
• Progressive retinal or optic nerve disease from any cause apart from glaucoma.
• 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 Screening Visit or an anticipated change in the dosage during the course of the study.
• Bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
• History of severe allergic rhinitis.
• Unwillingness to risk the possibility of darkened iris or eyelash changes.
• Women of childbearing potential not using reliable means of birth control for at least one month prior to the Screening/Baseline Visit.
• Women who are pregnant or lactating.
• Participation in any other investigational study within 30 days prior to the Screening Visit.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: DuoTrav; One drop self-administered topically to the study eye(s) once daily every evening at 8:00 pm for 12 weeks	Drug: Travoprost 0.004%/Timolol 0.5% Fixed Combination (DuoTrav); One drop self-administered topically to the study eye(s) once daily every evening at 8:00 pm for 12 weeks; Other Names: DuoTrav®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline (Day 0) in intraocular pressure (IOP) at final visit (Week 12)	As measured by Goldmann applanation tonometry. If only one eye qualifies for inclusion and treatment, this eye will be selected for analysis. If both eyes qualify and are treated, the worse evaluable eye will be selected for analysis. The worse eye will be the eye with the higher IOP at the screening/baseline visit. If both eyes are equal, the right eye will be selected for analysis.	Baseline (Day 0), Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects who reach target IOP (≤18 mmHg)	As measured by Goldmann applanation tonometry.	Week 12

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): February 1, 2013
• Study Completion (ACTUAL): February 1, 2013

Study Registration Dates

• First Submitted: September 27, 2012
• First Submitted That Met QC Criteria: September 27, 2012
• First Posted (ESTIMATE): October 1, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 7, 2013
• Last Update Submitted That Met QC Criteria: February 6, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Ocular hypertension; Glaucoma; Intraocular Pressure (IOP); DuoTrav; Beta-blocker; Prostaglandin analogue
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Timolol; Travoprost
• Other Study ID Numbers: RDG-11-257