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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

April 30, 2010
May 26, 2011
April 2010
May 2010   (final data collection date for primary outcome measure)
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
  • Mean Intraocular Pressure (IOP) change from baseline at 8 AM on Day 5 [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Mean IOP change from baseline at 8 PM on Day 5 [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01114893 on ClinicalTrials.gov Archive Site
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
Not Provided
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Travoprost Five Day Posology Study
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Open-angle Glaucoma (OAG)
  • Ocular Hypertension
  • 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
  • Drug: Travoprost Vehicle
    1 drop in each eye 8 times daily for 5 days
  • Drug: Travoprost (Groups A, B and C)
    1 drop in each eye 8 times daily for 5 days
  • Active Comparator: TRAVATAN
    TRAVATAN 0.004% once daily
    Intervention: Drug: Travoprost 0.004%
  • Placebo Comparator: Travoprost Vehicle
    Travoprost Vehicle
    Intervention: Drug: Travoprost Vehicle
  • Experimental: Travoprost Group A
    Travoprost Group A
    Intervention: Drug: Travoprost (Groups A, B and C)
  • Experimental: Travoprost Group B
    Travoprost Group B
    Intervention: Drug: Travoprost (Groups A, B and C)
  • Experimental: Travoprost Group C
    Travoprost Group C
    Intervention: Drug: Travoprost (Groups A, B and C)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
Not Provided
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01114893
C-09-075
No
Matt Walker, PhD, Alcon Research, Ltd
Alcon Research
Not Provided
Not Provided
Alcon Research
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP