Efficacy of Changing to TRAVATAN® From Prior Therapy

NCT ID: NCT01510145

Last Updated: 2014-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-05-31

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.

Conditions

Open-angle Glaucoma; Ocular Hypertension

Study Design

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

Study Groups

TRAVATAN® 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.

Group Type: EXPERIMENTAL

Travoprost 0.004% BAK-free

Intervention Type: DRUG

Containing Polyquad (PQ) preservative

Interventions

Travoprost 0.004% BAK-free

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;
• 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;

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;

• 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

Adriana S. Bonadia

Role: STUDY_DIRECTOR

Alcon Research

References

Lopes JF, Hubatsch DA, Amaris P. Effect of benzalkonium chloride-free travoprost on intraocular pressure and ocular surface symptoms in patients with glaucoma previously on latanoprost: an open-label study. BMC Ophthalmol. 2015 Nov 12;15:166. doi: 10.1186/s12886-015-0151-7.

Reference Type: DERIVED

PMID: 26563363 (View on PubMed)

Other Identifiers

RDG-10-300

Identifier Type: -

Identifier Source: org_study_id