Efficacy of Changing to TRAVATAN® From Prior Therapy

NCT01493427 | Completed Phase 4 Results

• 2 other identifiers: RDG-10-2982011-000161-13
• Study Type: interventional
• Target: 202
• Locations: 0 countries
• Sites: N/A

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

Keywords

Glaucoma; OAG; OHT

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Percentage of Patients With Target IOP (≤18 mmHg) at 12 Weeks

  Week 12

Study Arms (1)

TRAVATAN® BAK-free

EXPERIMENTAL

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

Drug: Travoprost 0.004%

Interventions

Travoprost 0.004% DRUG

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

Also known as: TRAVATAN® BAK-free

TRAVATAN® BAK-free

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Doug Hubatsch, Global Brand Leader, Medical Affairs
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Severine Durier, Pharm.D

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 16, 2011
• Study Start: December 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: May 19, 2014
• Results First Posted: May 9, 2014

Record last verified: 2014-05