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Divided Dose of TRAVATAN®

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01298687
First received: February 16, 2011
Last updated: July 28, 2014
Last verified: July 2014
History of Changes
  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 Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost
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 ] [ Designated as safety issue: No ]
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)
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.
  • 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: July 28, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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 September 27, 2016