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: July 28, 2014
Last verified: July 2014

February 16, 2011
July 28, 2014
February 2011
April 2011   (final data collection date for primary outcome measure)
24-hour Area Under the Curve (AUC) in IOP Reduction [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Mean 24 hour IOP change from baseline AUC at Day 5 [ Time Frame: Baseline to Day 5 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01298687 on ClinicalTrials.gov Archive Site
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Divided Dose of TRAVATAN®
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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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Open-angle Glaucoma
  • Ocular Hypertension
  • Drug: Travoprost Ophthalmic Solution, 0.00013%
    Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose
  • Drug: Travoprost Ophthalmic Solution, 0.00033%
    Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose
  • Drug: Travoprost Ophthalmic Solution, 0.001%
    Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
  • Drug: Travoprost Ophthalmic Solution, 0.00267%
    Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
  • Drug: Travoprost Ophthalmic Solution, 0.004%
    Other Name: TRAVATAN®
  • Drug: Travoprost Vehicle
    Inactive ingredients used as an active comparator
  • 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
    Intervention: Drug: Travoprost Ophthalmic Solution, 0.00013%
  • 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
    Intervention: Drug: Travoprost Ophthalmic Solution, 0.00033%
  • 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
    Intervention: Drug: Travoprost Ophthalmic Solution, 0.001%
  • 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
    Intervention: Drug: Travoprost Ophthalmic Solution, 0.00267%
  • 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)
    Intervention: Drug: Travoprost Ophthalmic Solution, 0.004%
  • Placebo Comparator: Vehicle
    Travoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days
    Intervention: Drug: Travoprost 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
April 2011
April 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.
  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01298687
C-10-081
No
Alcon Research
Alcon Research
Not Provided
Study Director: Matt Walker, PhD Alcon Research
Alcon Research
July 2014

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