Efficacy of Changing to DUOTRAV® From Prior Therapy

NCT ID: NCT01327599

Last Updated: 2014-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2012-11-30

Brief Summary

The purpose of this study was to assess the efficacy and tolerability of changing to DUOTRAV® from prior bimatoprost 0.03%/timolol 0.5% pharmacotherapy in subjects with open-angle glaucoma or ocular hypertension having uncontrolled intraocular pressure (IOP).

Conditions

Open-Angle Glaucoma; Ocular Hypertension; Pigment Dispersion Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DUOTRAV®

Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks

Group Type: EXPERIMENTAL

Travoprost 0.004%+Timolol 0.5% ophthalmic solution

Intervention Type: DRUG

Fixed dose combination topical ocular agent preserved with polyquaternium-1 (POLYQUAD)

Interventions

Travoprost 0.004%+Timolol 0.5% ophthalmic solution

Fixed dose combination topical ocular agent preserved with polyquaternium-1 (POLYQUAD)

Intervention Type: DRUG

Other Intervention Names

DUOTRAV®

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of ocular hypertension, open-angle or pigment dispersion glaucoma in at least one eye.
• Stable IOP-lowering regimen of bimatoprost 0.03%/timolol 0.5% therapy (either administered concomitantly or in a fixed combination) within 4 weeks prior to the screening visit.
• IOP considered to be safe (in the opinion of the investigator), in both eyes, to assure clinical stability of vision and the optic nerve throughout the study period.
• IOP between 19 to 35 mmHg (at any time of the day) in at least one eye (which would be designated as the study eye).
• 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.
• Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
• Sign informed consent.

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.
• A condition, which in the opinion of the Principal Investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
• Participation in any other investigational study within 30 days prior to the Screening Visit.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Severine Durier, Pharm.D

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

2011-000161-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RDG-10-272

Identifier Type: -

Identifier Source: org_study_id