Efficacy Study of Travoprost APS Versus TRAVATAN

Alcon

Status and phase: Completed; Phase 3

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Travoprost 0.004% (BAK-preserved) Eye Drops, Solution; Drug: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00848536

2008-006027-31 (EudraCT Number)

C-08-40

Details and patient eligibility

About

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

Enrollment: 371 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

• Other protocol-defined inclusion criteria may apply.

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.
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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371 participants in 2 patient groups

TRAVATAN APS

Experimental group

Description:

One drop once daily in the evening for 3 months

Treatment:

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

TRAVATAN

Active Comparator group

Description:

One drop once daily in the evening for 3 months

Treatment:

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