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®)

NCT ID: NCT01464424

Last Updated: 2013-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-06-30

Brief Summary

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.

Conditions

Glaucoma; Ocular Hypertension; Open-Angle Glaucoma

Keywords

Glaucoma; Ocular Hypertension; Open-Angle Glaucoma; Intraocular Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: OTHER

Travoprost 0.004% ophthalmic solution

Intervention Type: DRUG

Bimatoprost 0.01% ophthalmic solution

Intervention Type: DRUG

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

Group Type: OTHER

Travoprost 0.004% ophthalmic solution

Intervention Type: DRUG

Bimatoprost 0.01% ophthalmic solution

Intervention Type: DRUG

Interventions

Travoprost 0.004% ophthalmic solution

Intervention Type: DRUG

Bimatoprost 0.01% ophthalmic solution

Intervention Type: DRUG

Other Intervention Names

TRAVATAN® Z; LUMIGAN®

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Doug Hubatsch, MS

Role: STUDY_DIRECTOR

Alcon Research

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25432143 (View on PubMed)

Other Identifiers

RDG-10-003

Identifier Type: -

Identifier Source: org_study_id