Safety and Efficacy of Changing to DuoTrav From Prior Therapy

Assessing the Safety and Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients Uncontrolled on Bimatoprost 0.03%/Timolol 0.5% Therapy (Fixed or Unfixed)

The purpose of this study to assess the safety and efficacy of changing to DuoTrav® from prior bimatoprost 0.03%/timolol 0.5% (used concomitantly or in a fixed combination) pharmacotherapy in uncontrolled patients with open-angle glaucoma or ocular hypertension.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®)

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Schweinfurt, Germany, 97421

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:

• Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
• Must have an IOP of between 19 to 35 millimeters mercury (mmHg) (at any time of the day) in at least one eye (which would be designated as the study eye).
• Must be 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.
• Women who are pregnant or lactating.
• 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.
• Corneal dystrophies in either eye.
• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
• Bronchial asthma or a history of bronchial asthma, bronchial hyper-reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
• History of severe allergic rhinitis.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DuoTrav; One drop in study eye(s) once daily for 8 weeks	Drug: Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®); One drop in study eye(s) once daily for 8 weeks; Other Names: DuoTrav®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Intraocular Pressure (IOP) at 8 weeks from prior therapy (baseline)	Goldmann applanation tonometry will be performed at the baseline visit and 8-week visit to record intraocular pressure (IOP). The difference between the two readings will be recorded as the change in IOP. IOP will be recorded in mmHg.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of subjects who reach target IOP (≤18 mmHg)	Goldmann applanation tonometry will be performed at the 8-week visit to record intraocular pressure. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP ≤18 mmHg to the overall study population.	8 weeks

Collaborators and Investigators

• Sponsor: Alcon Research

Publications and helpful links

General Publications

• Scherzer ML, Liehneova I, Negrete FJ, Schnober D. Travoprost 0.004%/timolol 0.5% fixed combination in patients transitioning from fixed or unfixed bimatoprost 0.03%/timolol 0.5%. Adv Ther. 2011 Aug;28(8):661-70. doi: 10.1007/s12325-011-0043-z. Epub 2011 Jul 15.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: October 28, 2010
• First Submitted That Met QC Criteria: October 28, 2010
• First Posted (Estimate): October 29, 2010

Study Record Updates

• Last Update Posted (Estimate): November 21, 2016
• Last Update Submitted That Met QC Criteria: November 18, 2016
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Pharmaceutical Solutions; Timolol; Ophthalmic Solutions; Travoprost
• Other Study ID Numbers: RDG-10-243