Clinical trial NCT01664039: An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®
Official title: Assessing the Efficacy and Tolerability of TRAVATAN® Solution Without BAK, Containing Polyquad® Preservative (Travoprost 0.004%) Versus LUMIGAN® 0.01% Solution With BAK (Bimatoprost 0.01%) in Treatment Naïve Patients With Ocular Hypertension or Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Keywords: Glaucoma
Ocular hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2012-08-14
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
* Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
* IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
* Able to follow instructions and be willing and able to attend all study visits.
* Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
* Must read, sign, and date an Ethics Committee-approved informed consent form.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
* Any abnormality preventing reliable applanation tonometry in either eye.
* Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
* Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
* History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications).
* Contact lens wear.
* Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
* Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
* Women of childbearing potential not using reliable means of birth control, are pregnant, or lactating.
* Unwilling to risk the possibility of darkened iris or eyelash changes.
* Participation in any other investigational study within 30 days prior to the Screening Visit.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Change From Baseline in Intraocular Pressure (IOP) at Month 6
timeFrame: Baseline (Day 0), Month 6
Secondary outcomes:
measure: Mean Change From Baseline in IOP at Week 6 and Month 3
timeFrame: Baseline (Day 0), Week 6, Month 3
measure: Percentage of Subjects Who Reached Target IOP at Each Visit
timeFrame: Week 6, Month 3, Month 6
measure: Number of Subjects With Change From Baseline in Ocular Hyperaemia by Grade at Each Visit
timeFrame: Baseline (Day 0), Week 6, Month 3, Month 6
measure: Number of Subjects With Change From Baseline in Corneal Staining by Grade at Month 3 and Month 6
timeFrame: Baseline (Day 0), Month 3, Month 6
measure: Number of Subjects With Change From Baseline in Conjunctiva Staining by Grade at Month 3 and Month 6
timeFrame: Baseline (Day 0), Month 3, Month 6
measure: Mean Change From Baseline in Ocular Surface Disease Index (OSDI) Score at Month 3 and Month 6
timeFrame: Baseline (Day 0), Month 3, Month 6
measure: Mean Change From Baseline In Tear Film Break Up Time (TBUT) at Month 3 and Month 6
timeFrame: Baseline (Day 0), Month 3, Month 6
Other outcomes:
Locations:
Study officials:
References: