Efficacy of Changing to TRAVATAN® From Prior Therapy

Phase 4

Completed

• Conditions: Open-angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Travoprost 0.004% BAK-free

• Registration Number: NCT01510145
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® solution without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to tolerability issues.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2012-01-11
• Study First Submitted QC: 2012-01-11
• Study First Posted: 2012-01-13
• Study Start: 2012-02
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-05
• Results First Submitted: 2014-05-15
• Results First Submitted QC: 2014-05-15
• Last Update Submitted: 2014-05-15
• Results First Posted: 2014-06-13
• Last Update Posted: 2014-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

Inclusion Criteria

• Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye;
• On latanoprost ophthalmic solution 0.005% monotherapy (including BAK-containing generics) for at least 4 weeks prior to the Screening Visit, but would benefit from a switch to TRAVATAN® BAK-free because of tolerability issues, in the opinion of the investigator;
• Intraocular pressure (IOP) <30 millimeters of mercury (mmHg) in both eyes while on latanoprost ophthalmic solution 0.005% monotherapy;
• IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period;
• Willing to discontinue the use of all other ocular hypotensive medications 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 Snellen visual acuity of 6/60 (20/200; 1.0 LogMAR) or better in each eye;
• Must sign an informed consent form;
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator;
• Any abnormality preventing reliable applanation tonometry in either eye;
• Corneal dystrophies in either eye;
• Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye;
• Any clinically significant, serious, or severe medical condition;
• Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study;
• Severe dry eye or keratoconjunctivitis sicca which has been or is currently being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids;
• Intraocular conventional surgery or laser surgery in either eye less than 3 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;
• Women who are pregnant, lactating, or not using reliable means of birth control;
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRAVATAN® BAK-free	Travoprost 0.004% BAK-free	Travoprost 0.004% BAK-free, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)	Baseline, Week 12	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Reach Target IOP (≤18 mmHg)	Week 12	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.