Clinical trial NCT01464424: 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®)
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®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Open-Angle Glaucoma
Keywords: Glaucoma
Ocular Hypertension
Open-Angle Glaucoma
Intraocular Pressure
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2011-11-03
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.
* 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.

Primary outcomes:
measure: Overall Mean Intraocular Pressure (IOP)
timeFrame: Week 6
Secondary outcomes:
measure: Mean IOP at Each After Office Hour Evaluation Timepoint
timeFrame: Week 6: 4 pm, 6 pm, 8 pm
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Doug Hubatsch, MS
role: STUDY_DIRECTOR
References:
citation: 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.