Efficacy of Changing to TRAVATAN® From Prior Therapy

Ocular Hypertension Clinical Trial

Official title:

Multi-Center Study Comparing Efficacy and Tolerability of TRAVATAN® BAK-free (0.004% Travoprost) in Patients Previously on Latanoprost Ophthalmic Solution 0.005% Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510145
• Other study ID #: RDG-10-300
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2012
• Last updated: May 15, 2014
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics CommitteeChile: Institutional Review BoardColombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

Drug:
• Travoprost 0.004% BAK-free
Containing Polyquad (PQ) preservative

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)	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.	Baseline, Week 12	No
Secondary	Percentage of Subjects Who Reach Target IOP (=18 mmHg)	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.	Week 12	No