Assessment of Intraocular Pressure (IOP) Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®)

Assessment of Late Day IOP Control in Subjects With Open-Angle Glaucoma or Ocular Hypertension Treated With Travoprost 0.004% (TRAVATAN® Z) or Bimatoprost 0.01% (LUMIGAN®)

The purpose of this study was to assess efficacy and tolerability of travoprost 0.004% vs. bimatoprost 0.01% during the after office hour period (4 pm to 8 pm) in subjects with open-angle glaucoma or ocular hypertension after 6 weeks of treatment.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Glaucoma; Open-Angle Glaucoma
• Intervention / Treatment: Drug: Travoprost 0.004% ophthalmic solution; Drug: Bimatoprost 0.01% ophthalmic solution

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of open-angle glaucoma (OAG) or ocular hypertension (OHT) in at least one eye.
• Non-study eye: Intraocular pressure (IOP) able to be controlled with no pharmacologic therapy or on the study medicine alone.
• Willing to discontinue the use of all other ocular hypotensive medications prior to receiving study medication and for the entire course of the study.
• Able to follow instructions, self instill study article, and attend all study visits.
• Best-corrected Snellen visual acuity of 20/200 or better in each eye.
• Sign Ethics Committee reviewed and approved informed consent form.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known medical history of allergy, hypersensitivity or poor tolerance to any component of the preparations used in this study.
• Any abnormality preventing applanation tonometry in either eye.
• Dry eye previously or currently being treated with punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids.
• Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
• Intraocular conventional or laser surgery >3 months prior to consent.
• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
• Progressive retinal or optic nerve disease from any cause.
• Use of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to Screening or an anticipated change in dosage during the course of the study.
• Any clinically significant, serious, or severe medical condition.
• Women of childbearing potential who are pregnant, lactating, or not using reliable means of birth control.
• Participation in any other study within 30 days prior to Screening.
• Use of any systemic (oral), injectable or topical steroids.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: TRAVATAN, then LUMIGAN; Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks	Drug: Travoprost 0.004% ophthalmic solution; Other Names: TRAVATAN® Z; Drug: Bimatoprost 0.01% ophthalmic solution; Other Names: LUMIGAN®
Other: LUMIGAN, then TRAVATAN; Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks	Drug: Travoprost 0.004% ophthalmic solution; Other Names: TRAVATAN® Z; Drug: Bimatoprost 0.01% ophthalmic solution; Other Names: LUMIGAN®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Mean Intraocular Pressure (IOP)	IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm) for an overall mean. The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye. Per-protocol dataset was pre-specified for this non-inferiority analysis.	Week 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean IOP at Each After Office Hour Evaluation Timepoint	IOP was measured at three after office hour evaluation time points (4 pm, 6 pm, and 8 pm). The three timepoints correspond to 20, 22, and 24 hours post dose. Efficacy analysis was performed for one eye only, i.e., the designated study eye.	Week 6: 4 pm, 6 pm, 8 pm

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Doug Hubatsch, MS, Alcon Research

Publications and helpful links

General Publications

• DuBiner HB, Hubatsch DA. Late-day intraocular pressure-lowering efficacy and tolerability of travoprost 0.004% versus bimatoprost 0.01% in patients with open-angle glaucoma or ocular hypertension: a randomized trial. BMC Ophthalmol. 2014 Nov 28;14:151. doi: 10.1186/1471-2415-14-151.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: November 1, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 3, 2011

Study Record Updates

• Last Update Posted (Estimate): September 13, 2013
• Last Update Submitted That Met QC Criteria: September 5, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Intraocular Pressure; Ocular Hypertension; Open-Angle Glaucoma; Glaucoma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost; Bimatoprost
• Other Study ID Numbers: RDG-10-003