Divided Dose of TRAVATAN® - Full Text View

Purpose

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).

Condition	Intervention	Phase
Open-angle Glaucoma Ocular Hypertension	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	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Travoprost

Genetic and Rare Diseases Information Center resources: Pigment-dispersion Syndrome

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

24-hour Area Under the Curve (AUC) in IOP Reduction [ Time Frame: Day 5 ]


Enrollment:	67
Study Start Date:	February 2011
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298687

Sponsors and Collaborators

Alcon Research

Investigators


Study Director:	Matt Walker, PhD	Alcon Research

More Information


Responsible Party:	Alcon Research
ClinicalTrials.gov Identifier:	NCT01298687 History of Changes
Other Study ID Numbers:	C-10-081
Study First Received:	February 16, 2011
Last Updated:	May 3, 2017

Keywords provided by Alcon Research:


open-angle glaucoma ocular hypertension divided dose

Additional relevant MeSH terms:


Hypertension Glaucoma Glaucoma, Open-Angle Ocular Hypertension Vascular Diseases Cardiovascular Diseases	Eye Diseases Pharmaceutical Solutions Ophthalmic Solutions Travoprost Antihypertensive Agents

ClinicalTrials.gov processed this record on August 17, 2017