Dry Eye Disease Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-Masked Study of Safety and Efficacy of Vismed® in Dry Eye Syndrome
Verified date | January 2009 |
Source | Lantibio |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The study is designed to assess the safety and efficacy of Vismed®, a special eye drop containing sodium hyaluronate, in the treatment of dry eye syndrome. Vismed® is being compared to another eye drop, identical in composition except that it does not contain the active ingredient, sodium hyaluronate. This eye drop is designed as the "vehicle." Some subjects are to receive Vismed® treatment, while others are to receive the vehicle; the assignment of subjects to receive either Vismed or vehicle is to be random. The two-week treatment phase is followed by a one week follow-up period to evaluate safety of Vismed®.
Status | Completed |
Enrollment | 300 |
Est. completion date | May 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male and female adults aged 18 years and over. - Subjects should have at least a 3-month documented history of dry eye in both eyes diagnosed as dry eye syndrome, keratoconjunctivitis sicca (KCS), or due to Sjögren syndrome (immune exocrinopathy). - Subjects must agree to discontinue all artificial tears from Screening through the duration of the treatment period (Screening to Day 14). - Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening. - Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study. - Subjects must provide signed informed consent prior to participation in any study-related procedures. Exclusion Criteria: - Pregnancy or lactation. - Females of childbearing potential who are not using systemic contraception, are not postmenopausal (= 1 year), or are not surgically sterilized. - Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening. - Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication. - Any active inflammation of the eye not due to KCS (eg, iritis, scleritis, etc.). - Participation in any other clinical trial within 30 days prior to Screening. - Prior participation in a previous clinical trial of Vismed®. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Florida Eye Microsurgical Institute | Boynton Beach | Florida |
United States | Charlotte Eye, Ear, Nose and Throat | Charlotte | North Carolina |
United States | Chattanooga Eye Institute | Chattanooga | Tennessee |
United States | Center for Excellence in Eye Care | Miami | Florida |
United States | Ophthalmic Research & Clinical Studies | Moon Twp | Pennsylvania |
United States | American Eye Institute | New Albany | Indiana |
United States | Abrams Eye Center | Stuart | Florida |
United States | East Florida Eye Institutue | Stuart | Florida |
United States | International Eye Center | Tampa | Florida |
United States | Comprehensive Eye Care | Washington | Missouri |
Lead Sponsor | Collaborator |
---|---|
Lantibio | River Plate Biotechnology, Inc., Rx Development Resources, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | staining of the cornea and conjunctiva | Day 7 | No | |
Primary | symptom frequency score | Day 7 | No | |
Secondary | staining of the cornea and conjunctiva | Day 14 | No | |
Secondary | symptom frequency score | Day 14 | No | |
Secondary | Quality of Life assessment | Day 7 and Day 14 | No |
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