Divided Dose of TRAVATAN®

Alcon

Status and phase: Completed; Phase 2

Conditions: Open-angle Glaucoma; Ocular Hypertension

Treatments: Drug: Travoprost Ophthalmic Solution, 0.001%; Drug: Travoprost Ophthalmic Solution, 0.00013%; Drug: Travoprost Ophthalmic Solution, 0.00267%; Drug: Travoprost Ophthalmic Solution, 0.004%; Drug: Travoprost Vehicle; Drug: Travoprost Ophthalmic Solution, 0.00033%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01298687

C-10-081

Details and patient eligibility

About

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).

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 6 patient groups, including a placebo group

Trav 0.00013%

Experimental group

Description:

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

Treatment:

Drug: Travoprost Ophthalmic Solution, 0.00013%

Trav 0.00033%

Experimental group

Description:

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

Treatment:

Drug: Travoprost Ophthalmic Solution, 0.00033%

Trav 0.001%

Experimental group

Description:

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

Treatment:

Drug: Travoprost Ophthalmic Solution, 0.001%

Trav 0.00267%

Experimental group

Description:

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

Treatment:

Drug: Travoprost Ophthalmic Solution, 0.00267%

TRAVATAN

Active Comparator group

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)

Treatment:

Drug: Travoprost Ophthalmic Solution, 0.004%

Vehicle

Placebo Comparator group

Description:

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

Treatment:

Drug: Travoprost Vehicle