Travoprost Five Day Posology Study

Alcon

Status and phase: Completed; Phase 2

Conditions: Ocular Hypertension; Open-angle Glaucoma (OAG)

Treatments: Drug: Travoprost (Groups A, B and C); Drug: Travoprost 0.004%; Drug: Travoprost Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01114893

C-09-075

Details and patient eligibility

About

The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. either sex and any race/ethnicity, ≥18 years old

2. diagnosed with open-angle glaucoma, and/or ocular hypertension

3. meets the following IOP entry criteria:

   • Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
   • Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1

4. satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion criteria

1. females of childbearing potential not meeting protocol conditions
2. angle grade less than Grade 2 in either eye
3. cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
4. severe central visual field loss in either eye
5. any abnormality preventing reliable applanation tonometry in either eye
6. hypersensitivity to prostaglandin analogues or to any component of the study medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 5 patient groups, including a placebo group

TRAVATAN

Active Comparator group

Description:

TRAVATAN 0.004% once daily

Treatment:

Drug: Travoprost 0.004%

Travoprost Vehicle

Placebo Comparator group

Description:

Travoprost Vehicle

Treatment:

Drug: Travoprost Vehicle

Travoprost Group A

Experimental group

Description:

Travoprost Group A

Treatment:

Drug: Travoprost (Groups A, B and C)

Travoprost Group B

Experimental group

Description:

Travoprost Group B

Treatment:

Drug: Travoprost (Groups A, B and C)

Travoprost Group C

Experimental group

Description:

Travoprost Group C

Treatment:

Drug: Travoprost (Groups A, B and C)