Travoprost Five Day Posology Study

This study has been completed.
Sponsor:
Information provided by:
Alcon Research
ClinicalTrials.gov Identifier:
NCT01114893
First received: April 30, 2010
Last updated: May 26, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to determine the safety and efficacy of three concentrations of travoprost ophthalmic solution (Groups A, B and C) administered eight times daily.


Condition Intervention Phase
Open-angle Glaucoma (OAG)
Ocular Hypertension
Drug: Travoprost 0.004%
Drug: Travoprost Vehicle
Drug: Travoprost (Groups A, B and C)
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 Intraocular Pressure (IOP) Change From Baseline at 8 AM on Day 5 [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Outcome measure shows how each treatment reduced eye pressure at 8 AM on Day 5 compared to the eye pressure at 8 AM before the start of treatment


Secondary Outcome Measures:
  • IOP Change From Baseline at 8 PM on Day 5 [ Time Frame: 5 Days ] [ Designated as safety issue: No ]
    Outcome measure shows how each treatment reducted eye pressure at 8 PM on Day 5 compared to the eye pressure at 8 PM before the start of treatment


Enrollment: 60
Study Start Date: April 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: TRAVATAN
TRAVATAN 0.004% once daily
Drug: Travoprost 0.004%
1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days
Placebo Comparator: Travoprost Vehicle
Travoprost Vehicle
Drug: Travoprost Vehicle
1 drop in each eye 8 times daily for 5 days
Experimental: Travoprost Group A
Travoprost Group A
Drug: Travoprost (Groups A, B and C)
1 drop in each eye 8 times daily for 5 days
Experimental: Travoprost Group B
Travoprost Group B
Drug: Travoprost (Groups A, B and C)
1 drop in each eye 8 times daily for 5 days
Experimental: Travoprost Group C
Travoprost Group C
Drug: Travoprost (Groups A, B and C)
1 drop in each eye 8 times daily for 5 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. either sex and any race/ethnicity, ≥18 years old
  2. diagnosed with open-angle glaucoma, and/or ocular hypertension
  3. meets the following IOP entry criteria:

    • Mean IOP ≥ 24 millimeters mercury (mmHg) in at least 1 eye, with the same eye qualifying at 8 AM on both the Eligibility Visit (Day 0) and Day 1
    • Mean IOP ≤ 36 mmHg in both eyes at 8 AM and 8 PM at the Eligibility Visit (Day 0), and at 8 AM on Day 1
  4. satisfies all informed consent requirements; able to read, sign and date the informed consent

Exclusion Criteria:

  1. females of childbearing potential not meeting protocol conditions
  2. angle grade less than Grade 2 in either eye
  3. cup to disc ratio greater than 0.8 (horizontal or vertical measurement) in either eye
  4. severe central visual field loss in either eye
  5. any abnormality preventing reliable applanation tonometry in either eye
  6. hypersensitivity to prostaglandin analogues or to any component of the study medication
  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: NCT01114893

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: Matt Walker, PhD, Alcon Research, Ltd
ClinicalTrials.gov Identifier: NCT01114893     History of Changes
Other Study ID Numbers: C-09-075
Study First Received: April 30, 2010
Results First Received: May 26, 2011
Last Updated: May 26, 2011
Health Authority: United States: Food and Drug Administration

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 August 28, 2014