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®)

Alcon

Status and phase: Completed; Phase 4

Conditions: Open-Angle Glaucoma; Glaucoma; Ocular Hypertension

Treatments: Drug: Bimatoprost 0.01% ophthalmic solution; Drug: Travoprost 0.004% ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01464424

RDG-10-003

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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84 participants in 2 patient groups

TRAVATAN, then LUMIGAN

Other group

Description:

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

Treatment:

Drug: Travoprost 0.004% ophthalmic solution

Drug: Bimatoprost 0.01% ophthalmic solution

LUMIGAN, then TRAVATAN

Other group

Description:

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

Treatment:

Drug: Travoprost 0.004% ophthalmic solution

Drug: Bimatoprost 0.01% ophthalmic solution