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®)

Glaucoma Clinical Trial

Official title:

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®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01464424
• Other study ID #: RDG-10-003
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2011
• Last updated: September 5, 2013
• Start date: October 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

Drug:
• Travoprost 0.004% ophthalmic solution

• Bimatoprost 0.01% ophthalmic solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No