Efficacy of Changing to TRAVATAN® From Prior Therapy

Ocular Hypertension Clinical Trial

Official title:

Multi-Center Study Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (0.004% Travoprost) in Patients Previously on Latanoprost 0.005% or Bimatoprost 0.01% Ophthalmic Solution Monotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493427
• Other study ID #: RDG-10-298
• Secondary ID: 2011-000161-13
• Status: Completed
• Phase: Phase 4
• First received: December 14, 2011
• Last updated: May 9, 2014
• Start date: December 2011
• Est. completion date: February 2013

Study information

• Verified date: May 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeSpain: Ethics CommitteeSweden: Institutional Review BoardItaly: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 202
• Est. completion date: February 2013
• Est. primary completion date: February 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.

• 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

• 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.

• 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.

• Other protocol-defined exclusion criteria may apply.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Travoprost 0.004%
Travoprost 0.004% without benzalkonium chloride (BAK), 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	Mean 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 Patients With Target IOP (=18 mmHg) at 12 Weeks	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