Efficacy of Changing to TRAVATAN® From Prior Therapy

NCT ID: NCT01493427

Last Updated: 2014-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-02-28

Brief Summary

The purpose of this study was to assess the efficacy and tolerability of TRAVATAN® Solution without benzalkonium chloride (BAK) in patients previously on latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Study Design

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

Study Groups

TRAVATAN® BAK-free

Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks

Group Type: EXPERIMENTAL

Travoprost 0.004%

Intervention Type: DRUG

Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative

Interventions

Travoprost 0.004%

Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative

Intervention Type: DRUG

Other Intervention Names

TRAVATAN® BAK-free

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye.
• Be on either latanoprost 0.005% or bimatoprost 0.01% ophthalmic solution monotherapy (including BAK-containing generics) for at least four weeks prior to Screening visit.
• Would benefit from a switch to TRAVATAN® Solution without BAK containing Polyquad® Preservative due to tolerability issues, in the opinion of the investigator.
• 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.
• Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye

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.
• Severe dry eye or related which has been or currently is being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
• Any clinically significant, serious, or severe medical condition.
• Intraocular conventional surgery or laser surgery in either eye less than three months prior to 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.
• Women not using reliable means of birth control.
• Use of any systemic medication known to affect IOP which has not been on stable course for at least 7 days prior to Screening Visit.
• Any clinically significant, serious, or severe medical condition.
• Participation in any other investigational study within 30 days of 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-10-298

Identifier Type: -

Identifier Source: org_study_id