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Divided Dose of TRAVATAN®

Primary Purpose

Open-angle Glaucoma, Ocular Hypertension

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Travoprost Ophthalmic Solution, 0.00013%

Travoprost Ophthalmic Solution, 0.00033%

Travoprost Ophthalmic Solution, 0.001%

Travoprost Ophthalmic Solution, 0.00267%

Travoprost Ophthalmic Solution, 0.004%

Travoprost Vehicle

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring open-angle glaucoma, ocular hypertension, divided dose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Trav 0.00013%

Trav 0.00033%

Trav 0.001%

Trav 0.00267%

TRAVATAN

Vehicle

Arm Description

Travoprost Ophthalmic Solution, 0.00013%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days

Travoprost Ophthalmic Solution, 0.00033%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days

Travoprost Ophthalmic Solution, 0.001%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days

Travoprost Ophthalmic Solution, 0.00267%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days

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)

Travoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days

Outcomes

Primary Outcome Measures

24-hour Area Under the Curve (AUC) in IOP Reduction

Secondary Outcome Measures

Full Information

NCT ID

NCT01298687

First Posted

February 16, 2011

Last Updated

May 3, 2017

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01298687

Brief Title

Divided Dose of TRAVATAN®

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Open-angle Glaucoma, Ocular Hypertension

Keywords

open-angle glaucoma, ocular hypertension, divided dose

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Trav 0.00013%

Arm Type

Experimental

Arm Description

Travoprost Ophthalmic Solution, 0.00013%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days

Arm Title

Trav 0.00033%

Arm Type

Experimental

Arm Description

Travoprost Ophthalmic Solution, 0.00033%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days

Arm Title

Trav 0.001%

Arm Type

Experimental

Arm Description

Travoprost Ophthalmic Solution, 0.001%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days

Arm Title

Trav 0.00267%

Arm Type

Experimental

Arm Description

Travoprost Ophthalmic Solution, 0.00267%, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days

Arm Title

TRAVATAN

Arm Type

Active Comparator

Arm Description

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)

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

Travoprost vehicle, 1 drop administered in each eye 12 times per day at 2-hour intervals for 5 days

Intervention Type

Drug

Intervention Name(s)

Travoprost Ophthalmic Solution, 0.00013%

Intervention Description

Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose

Intervention Type

Drug

Intervention Name(s)

Travoprost Ophthalmic Solution, 0.00033%

Intervention Description

Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose

Intervention Type

Drug

Intervention Name(s)

Travoprost Ophthalmic Solution, 0.001%

Intervention Description

Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose

Intervention Type

Drug

Intervention Name(s)

Travoprost Ophthalmic Solution, 0.00267%

Intervention Description

Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose

Intervention Type

Drug

Intervention Name(s)

Travoprost Ophthalmic Solution, 0.004%

Other Intervention Name(s)

TRAVATAN®

Intervention Type

Drug

Intervention Name(s)

Travoprost Vehicle

Intervention Description

Inactive ingredients used as an active comparator

Primary Outcome Measure Information:

Title

24-hour Area Under the Curve (AUC) in IOP Reduction

Time Frame

Day 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with open-angle glaucoma or ocular hypertension who meet the following IOP criteria: Mean IOP ≥ 24 mmHg in at least 1 eye, with the same eye qualifying at 8 AM at both Day 0 and Day 1; 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Matt Walker, PhD

Organizational Affiliation

Alcon Research

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Divided Dose of TRAVATAN®

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