Travoprost Five Day Posology Study

Alcon Research60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Open-angle Glaucoma (OAG)Ocular Hypertension

Interventions

Travoprost 0.004%DRUG

1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days

Travoprost VehicleDRUG

1 drop in each eye 8 times daily for 5 days

Travoprost (Groups A, B and C)DRUG

1 drop in each eye 8 times daily for 5 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Mean Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5

Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment

Time frame: 5 days

Secondary Outcomes

IOP Change From Baseline at 8 PM on Day 5

Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment

Time frame: 5 Days

Data from ClinicalTrials.gov

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