Divided Dose of TRAVATAN®

The purpose of this study is to compare the incremental dosing of travoprost ophthalmic solution versus once a day dosing of TRAVATAN® in lowering intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Open-angle Glaucoma
• Intervention / Treatment: Drug: Travoprost Ophthalmic Solution, 0.00013%; Drug: Travoprost Ophthalmic Solution, 0.00033%; Drug: Travoprost Ophthalmic Solution, 0.001%; Drug: Travoprost Ophthalmic Solution, 0.00267%; Drug: Travoprost Ophthalmic Solution, 0.004%; Drug: Travoprost Vehicle

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with open-angle glaucoma or ocular hypertension who meet the following IOP criteria:

  1. Mean IOP ≥ 24 mmHg in at least 1 eye, with the same eye qualifying at 8 AM at both Day 0 and Day 1;
  2. Mean IOP ≤ 36 mmHg in both eyes at all time points on Day 0 and Day 1.
• Must sign an informed consent form.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Females of childbearing potential who are pregnant, test positive on urine pregnancy test at the Screening Visit, intend to become pregnant during the study period, are breast-feeding, or are not using highly effective birth control measures.
• Current or history of ocular inflammation or infection in either eye within the past 3 months.
• Corneal thickness greater than 620 µm as determined by pachymetry in either eye.
• Severe visual field loss.
• Cup to disc ratio greater than 0.8 in either eye.
• Intraocular surgery within the past 6 months in either eye.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trav 0.00013%; Travoprost Ophthalmic Solution, 0.00013%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days	Drug: Travoprost Ophthalmic Solution, 0.00013%; Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose
Experimental: Trav 0.00033%; Travoprost Ophthalmic Solution, 0.00033%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days	Drug: Travoprost Ophthalmic Solution, 0.00033%; Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose
Experimental: Trav 0.001%; Travoprost Ophthalmic Solution, 0.001%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days	Drug: Travoprost Ophthalmic Solution, 0.001%; Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
Experimental: Trav 0.00267%; Travoprost Ophthalmic Solution, 0.00267%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days	Drug: Travoprost Ophthalmic Solution, 0.00267%; Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
Active Comparator: TRAVATAN; Travoprost Ophthalmic Solution, 0.004%, 1 drop administered in each eye at 8 pm for 5 days, with 1 drop of vehicle administered at all other timepoints (2-hour intervals)	Drug: Travoprost Ophthalmic Solution, 0.004%; Other Names: TRAVATAN®
Placebo Comparator: Vehicle; Travoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days	Drug: Travoprost Vehicle; Inactive ingredients used as an active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
24-hour Area Under the Curve (AUC) in IOP Reduction	Day 5

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Matt Walker, PhD, Alcon Research

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: February 16, 2011
• First Submitted That Met QC Criteria: February 16, 2011
• First Posted (Estimate): February 18, 2011

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: open-angle glaucoma; ocular hypertension; divided dose
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost
• Other Study ID Numbers: C-10-081