An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | December 2012 |
| End Date: | March 2014 |
| Contact: | Severine Durier, Medical Affairs EURMEA Manager |
| Phone: | + 33 1 47 10 48 43 |
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
The purpose of this study is evaluate effects of Travatan versus Lumigan on intraocular
pressure (IOP) and ocular surface and inflammatory biomarkers.
pressure (IOP) and ocular surface and inflammatory biomarkers.
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.
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