Divided Dose of Travatan - Full Text View

Purpose

The purpose of the study is to determine whether the same level of Intraocular Pressure (IOP) control is achieved if the daily dose of travoprost is divided into 12 fractions compared to once a day dosing. The study will also determine whether concentrations lower and higher than the one approved can result in better IOP lowering efficacy when divided into 12 fractions compared to once a day dosing.

Condition	Intervention	Phase
Open-angle Glaucoma and Ocular Hypertension	Drug: Travoprost Ophthalmic Solution, 0.00033% Drug: Travoprost Ophthalmic Solution, 0.00013% Drug: Travoprost Ophthalmic Solution, 0.001% Drug: Travoprost Ophthalmic Solution, 0.00267% Drug: Travatan 0.004% Drug: Travoprost Ophthalmic Solution Vehicle	Phase 2

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

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Travoprost

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Mean 24 hour IOP change from baseline AUC at Day 5 [ Time Frame: Baseline to Day 5 ] [ Designated as safety issue: No ]

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

Arms	Assigned Interventions
Experimental: Travoprost Ophthalmic Solution, 0.00033% The cumulative daily dose in this group equals to Travatan 0.004% once daily dose	Drug: Travoprost Ophthalmic Solution, 0.00033% 1 drop in each eye, administered every 2 hours for 5 days
Experimental: Travoprost Ophthalmic Solution, 0.00013% The cumulative daily dose in this group is below the Travatan 0.004% once daily dose	Drug: Travoprost Ophthalmic Solution, 0.00013% 1 drop in each eye, administered every 2 hours for 5 days
Experimental: Travoprost Ophthalmic Solution, 0.001% The cumulative daily dose in this group is above the Travatan 0.004% once daily dose	Drug: Travoprost Ophthalmic Solution, 0.001% 1 drop in each eye, administered every 2 hours for 5 days
Experimental: Travoprost Ophthalmic Solution, 0.00267% The cumulative daily dose in this group is above the Travatan 0.004% once daily dose	Drug: Travoprost Ophthalmic Solution, 0.00267% 1 drop in each eye, administered every 2 hours for 5 days
Active Comparator: Travatan 0.004% FDA approved concentration	Drug: Travatan 0.004% 1 drop in each eye administered at 8 PM; all the other time points vehicle is administered (every 2 hours)
Placebo Comparator: Travoprost Ophthalmic Solution, vehicle A vehicle arm is included to be able to compare the results to no treatment.	Drug: Travoprost Ophthalmic Solution Vehicle One drop in each eye, administered every 2 hours for 5 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Exclusion Criteria:

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

Contacts and Locations

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

Locations

United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

More Information

No publications provided

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:	November 7, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alcon Research:

open-angle glaucoma, ocular hypertension, divided dose

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Travoprost
Cloprostenol

Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013