Divided Dose of TRAVATAN®

NCT01298687 | Completed Phase 2

• 1 other identifier: C-10-081
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Open-angle Glaucoma; Ocular Hypertension

Keywords

open-angle glaucoma; ocular hypertension; divided dose

Outcome Measures

Primary Outcomes (1)

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

  Day 5

Study Arms (6)

Trav 0.00013%

EXPERIMENTAL

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

Drug: Travoprost Ophthalmic Solution, 0.00013%

Trav 0.00033%

EXPERIMENTAL

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

Drug: Travoprost Ophthalmic Solution, 0.00033%

Trav 0.001%

EXPERIMENTAL

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

Drug: Travoprost Ophthalmic Solution, 0.001%

Trav 0.00267%

EXPERIMENTAL

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

Drug: Travoprost Ophthalmic Solution, 0.00267%

TRAVATAN

ACTIVE COMPARATOR

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)

Drug: Travoprost Ophthalmic Solution, 0.004%

Vehicle

PLACEBO COMPARATOR

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

Drug: Travoprost Vehicle

Interventions

Travoprost Ophthalmic Solution, 0.00013% DRUG

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

Trav 0.00013%

Travoprost Ophthalmic Solution, 0.00033% DRUG

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

Trav 0.00033%

Travoprost Ophthalmic Solution, 0.001% DRUG

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

Trav 0.001%

Travoprost Ophthalmic Solution, 0.00267% DRUG

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

Trav 0.00267%

Travoprost Ophthalmic Solution, 0.004% DRUG

Also known as: TRAVATAN®

TRAVATAN

Travoprost Vehicle DRUG

Inactive ingredients used as an active comparator

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Travoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Cloprostenol; Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Matt Walker, PhD

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2011
• First Posted: February 18, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 5, 2017

Record last verified: 2014-07