Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Divided Dose of TRAVATAN®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01298687
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
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 or disease Intervention/treatment 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : February 2011
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Travoprost

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 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




Primary Outcome Measures :
  1. 24-hour Area Under the Curve (AUC) in IOP Reduction [ Time Frame: Day 5 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298687


Sponsors and Collaborators
Alcon Research
Investigators
Layout table for investigator information
Study Director: Matt Walker, PhD Alcon Research
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01298687    
Other Study ID Numbers: C-10-081
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: July 2014
Keywords provided by Alcon Research:
open-angle glaucoma
ocular hypertension
divided dose
Additional relevant MeSH terms:
Layout table for MeSH terms
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Travoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents