Efficacy of Changing to Travatan From Prior Therapy
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | January 2012 |
| End Date: | May 2013 |
| Contact: | Alcon Call Center |
| Phone: | 1-888-451-3937 |
Multi-Center Study Comparing Efficacy and Tolerability of TRAVATAN® BAK-free (0.004% Travoprost) in Patients Previously on Latanoprost Ophthalmic Solution 0.005% Monotherapy
The purpose of this study is to assess the efficacy and tolerability of TRAVATAN® solution
without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic
solution monotherapy in patients with open-angle glaucoma or ocular hypertension due to
tolerability issues.
Inclusion Criteria:
- 18 years of age or older.
- Clinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye.
- Be on a latanoprost ophthalmic solution 0.005% monotherapy (including BAK-containing
generics) for at least 4 weeks prior to the Screening Visit, but would benefit from a
switch to TRAVATAN® BAK-free because of tolerability issues, in the opinion of the
investigator.
- Intra-ocular pressure (IOP) ≤30 mmHg in both eyes while on latanoprost ophthalmic
solution 0.005% monotherapy.
- Willing to discontinue the use of all other ocular hypotensive medications prior to
receiving the study medication for the entire course of the study.
- Best corrected Snellen visual acuity of 6/60 (20/200; 1.0 LogMAR) or better in each
eye.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Known medical history of allergy, hypersensitivity, or poor tolerance to any
component of the preparations to be used in this study deemed clinically significant
in the opinion of the Principal Investigator.
- Any abnormality preventing reliable applanation tonometry in either eye.
- Corneal dystrophies.
- Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either
eye.
- Any clinically significant, serious, or severe medical condition.
- Use of any systemic medications known to affect IOP which have not been on a stable
course for at least 7 days prior to the Screening Visit or an anticipated change in
the dosage during the course of the study.
- Dry eye or keratoconjunctivitis sicca which has been or is currently being treated
with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular
corticosteroids.
- Other protocol-defined exclusion criteria may apply.
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