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

February 16, 2011
November 7, 2011
March 2011
March 2011   (final data collection date for primary outcome measure)
Mean 24 hour IOP change from baseline AUC at Day 5 [ Time Frame: Baseline to Day 5 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01298687 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Divided Dose of Travatan
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Open-angle Glaucoma and Ocular Hypertension
  • Drug: Travoprost Ophthalmic Solution, 0.00033%
    1 drop in each eye, administered every 2 hours for 5 days
  • Drug: Travoprost Ophthalmic Solution, 0.00013%
    1 drop in each eye, administered every 2 hours for 5 days
  • Drug: Travoprost Ophthalmic Solution, 0.001%
    1 drop in each eye, administered every 2 hours for 5 days
  • Drug: Travoprost Ophthalmic Solution, 0.00267%
    1 drop in each eye, administered every 2 hours for 5 days
  • Drug: Travatan 0.004%
    1 drop in each eye administered at 8 PM; all the other time points vehicle is administered (every 2 hours)
  • Drug: Travoprost Ophthalmic Solution Vehicle
    One drop in each eye, administered every 2 hours for 5 days
  • Experimental: Travoprost Ophthalmic Solution, 0.00033%
    The cumulative daily dose in this group equals to Travatan 0.004% once daily dose
    Intervention: Drug: Travoprost Ophthalmic Solution, 0.00033%
  • Experimental: Travoprost Ophthalmic Solution, 0.00013%
    The cumulative daily dose in this group is below the Travatan 0.004% once daily dose
    Intervention: Drug: Travoprost Ophthalmic Solution, 0.00013%
  • Experimental: Travoprost Ophthalmic Solution, 0.001%
    The cumulative daily dose in this group is above the Travatan 0.004% once daily dose
    Intervention: Drug: Travoprost Ophthalmic Solution, 0.001%
  • Experimental: Travoprost Ophthalmic Solution, 0.00267%
    The cumulative daily dose in this group is above the Travatan 0.004% once daily dose
    Intervention: Drug: Travoprost Ophthalmic Solution, 0.00267%
  • Active Comparator: Travatan 0.004%
    FDA approved concentration
    Intervention: Drug: Travatan 0.004%
  • Placebo Comparator: Travoprost Ophthalmic Solution, vehicle
    A vehicle arm is included to be able to compare the results to no treatment.
    Intervention: Drug: Travoprost Ophthalmic Solution Vehicle
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01298687
C-10-081
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
November 2011

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