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: November 7, 2011
Last verified: November 2011
  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:


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
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

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 July 22, 2014