Efficacy Study of Travoprost APS Versus TRAVATAN

NCT ID: NCT00848536

Last Updated: 2012-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 371 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-01-31

Brief Summary

A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypertension

Conditions

Open Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TRAVATAN APS

One drop once daily in the evening for 3 months

Group Type: EXPERIMENTAL

Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution

Intervention Type: DRUG

One drop once daily in the evening for 3 months

TRAVATAN

One drop once daily in the evening for 3 months

Group Type: ACTIVE_COMPARATOR

Travoprost 0.004% (BAK-preserved) Eye Drops, Solution

Intervention Type: DRUG

One drop once daily in the evening for 3 months

Interventions

Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution

One drop once daily in the evening for 3 months

Intervention Type: DRUG

Travoprost 0.004% (BAK-preserved) Eye Drops, Solution

One drop once daily in the evening for 3 months

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older, either gender and any race.
• Open Angle Glaucoma (OAG) or Ocular Hypertension (OHT).
• Not currently on any IOP-lowering medication or currently on a stable treatment (i.e, at least 30 days) with and IOP-lowering monotherapy.
• All patients: Mean IOP in same eye (at both Eligibility 1 & 2 Visits):

≥ 24 and ≤ 36 mmHg at 9 AM; and ≥ 21 and ≤ 36 mmHg at 11 AM & 4 PM.

Exclusion Criteria

• Females of childbearing potential not meeting conditions set in the protocol.
• Severe central visual field loss.
• Angle Shaffer grade < 2.
• Cup/disc ratio > 0.8 (horizontal or vertical measurement).
• Best corrected visual acuity (VA) score worse than 55 ETDRS letters read (equivalent to approximately 20/80 Snellen or 0.25 decimal).
• Intraocular surgery or trauma within last 6 months.
• Any abnormality preventing reliable applanation tonometry.
• History of or current ocular pathology (including severe dry eye) that would affect the conduct of the study.
• Allergy/hypersensitivity to study medications.
• Unable to discontinue use of all IOP-lowering medications for a minimum wash-out period of 5 to 28 days prior to the Eligibility Visit.
• Less than 30 days stable dosing regimen of medications used on a chronic basis that may affect IOP.
• Use of any additional topical or systemic ocular hypotensive medication during the study.
• Therapy with another investigational agent within 30 days prior to the 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

Other Identifiers

2008-006027-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C-08-40

Identifier Type: -

Identifier Source: org_study_id