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| Sponsor: | Ophthalmic Consultants of Long Island |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | Ophthalmic Consultants of Long Island |
| ClinicalTrials.gov Identifier: | NCT00799682 |
Purpose
The purpose of this study is to determine if there is a difference in the ocular signs and symptoms of subjects' eyes using Xalatan® 0.005% versus Travatan Z® 0.004% based on the outcome of subject assessment and clinical assessment in patients with Ocular Hypertension or Glaucoma with mild to moderate dry eye at baseline in accordance with the Oxford Grading Scale.
| Condition | Intervention | Phase |
|---|---|---|
|
Dry Eye Disease |
Drug: Xalatan Drug: Travatan Z |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Supportive Care |
| Official Title: | An 8 Week, Single Masked, Parallel-Group, Exploratory Study Comparing Ocular Surface Signs and Symptoms in Monotherapy Ocular Hypertension or Glaucoma Patients Randomized to Either Xalatan® or Travatan Z® |
| Enrollment: | 56 |
| Study Start Date: | October 2008 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Xalatan® |
Drug: Xalatan
0.005% 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m.
Other Name: Topical Prostaglandin, Latanoprost Ophthalmic Solution
|
| Active Comparator: Travatan Z® |
Drug: Travatan Z
0.004%, 1 drop in each eye daily between 7:00 p.m. and 9:00 p.m.
Other Name: Topical Prostaglandin, Travaprost Ophthalmic Solution
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Ophthalmic Consultants of Long Island | |
| East Meadow, New York, United States, 11554 | |
| Ophthalmic Consultants of Long Island | |
| Lynbrook, New York, United States, 11563 | |
| Ophthalmic Consultants of Long Island | |
| Rockville Centre, New York, United States, 11570 | |
| Ophthalmic Consultants of Long Island | |
| Stony Brook, New York, United States, 11790 | |
| Ophthalmic Consultants of Long Island | |
| Valley Stream, New York, United States, 11581 | |
| Principal Investigator: | Marguerite McDonald, M.D. | Ophthalmic Consultants of Long Island |
| Study Director: | Barbara Burger, R.N. | Ophthalmic Consultans of Long Island |
More Information
| Responsible Party: | Marguerite McDonald, M.D., Ophthalmic Consultants of Long Island |
| ClinicalTrials.gov Identifier: | NCT00799682 History of Changes |
| Other Study ID Numbers: | GA6111ZH |
| Study First Received: | November 26, 2008 |
| Last Updated: | July 20, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
Dry Eye Monotherapy for Ocular Hypertension, Glaucoma Ocular Hypertension Chronic Open-Angle Glaucoma Chronic Angle-Closure Glaucoma Iridotomy |
Iridectomy Pseudo Exfoliate Pigmentary Glaucoma Systemic Non-Glaucoma Medications Hyperemia |
|
Keratoconjunctivitis Sicca Dry Eye Syndromes Eye Diseases Glaucoma Hypertension Ocular Hypertension Signs and Symptoms Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis |
Corneal Diseases Lacrimal Apparatus Diseases Vascular Diseases Cardiovascular Diseases Latanoprost Travoprost Antihypertensive Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |