- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00599716
Safety and Efficacy Assessment of Vismed® (Sodium Hyaluronate) for the Treatment of Dry Eye Syndrome
A Phase 3, Multicenter, Randomized, Double-Masked Study of Safety and Efficacy of Vismed® in Dry Eye Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
VISMED® is currently marketed in Europe under the CE mark as a viscoelastic lubricant eye drop. The proprietary formulation contains a highly purified specific fraction of sodium hyaluronate. Sodium hyaluronate is a natural polymer which is also present in the structures of the human eye. Its main physical characteristic is viscoelasticity. This means that VISMED® has a high viscosity between blinks and a low viscosity during blinking ensuring efficient coating of the surface of the eye. It is believed that this protective coating of the surface of the eye helps prevent dryness and irritation. Sodium hyaluronate also possesses mucoadhesive properties and the ability to entrap water, thus resembling tear mucus glycoprotein. This, together with the coating properties of sodium hyaluronate, results in an increased pre-corneal residence time and tear film break-up time (BUT) and therefore longer lubrication of the eye surface. VISMED® is completely free of preservatives. As a result, it is non-irritating to ocular tissues and can be used frequently and for extended periods without harming the surface of the eye (e.g. without causing superficial punctate keratitis). Some preservatives are known to cause toxic or allergic reactions, the symptoms of which include stinging, burning and redness of the eyes. To further maximize patient comfort, the pH of VISMED® is adjusted to 7.3, similar to that of the natural tear film.
Hydrogels of sodium hyaluronate have been used for many years in ophthalmic surgery in Europe and the U.S. to maintain the shape of the eye, to cover surgical instruments and to protect the corneal endothelium from damage. They have unique physical properties that make them ideal for use in the treatment of Dry Eye Syndrome. Therefore, VISMED® represents a new class of compound in development for the treatment of dry eye in the US, offering lubricant properties which can alleviate the discomfort and reverse ocular damage caused by dry eye syndrome.
This study is being conducted to supplement the body of knowledge gained from studies conducted in Europe and regulatory approvals granted there to formalize the safety and efficacy of Vismed® to meet FDA requirements for a New Drug Application to market the product in the US.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Florida
-
Boynton Beach, Florida, United States, 33426
- Florida Eye Microsurgical Institute
-
Miami, Florida, United States, 33176
- Center for Excellence in Eye Care
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Stuart, Florida, United States, 34994
- East Florida Eye Institutue
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Stuart, Florida, United States, 44115
- Abrams Eye Center
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Tampa, Florida, United States, 33603
- International Eye Center
-
-
Indiana
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New Albany, Indiana, United States, 47150
- American Eye Institute
-
-
Missouri
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Washington, Missouri, United States, 63090
- Comprehensive Eye Care
-
-
North Carolina
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Charlotte, North Carolina, United States, 28210
- Charlotte Eye, Ear, Nose and Throat
-
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Pennsylvania
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Moon Twp, Pennsylvania, United States, 15108
- Ophthalmic Research & Clinical Studies
-
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Tennessee
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Chattanooga, Tennessee, United States, 37411
- Chattanooga Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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®.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
study drug
|
a sterile, unpreserved eye drop containing sodium hyaluronate in a proprietary formulation to be administered by ocular instillation
Other Names:
|
Placebo Comparator: 2
vehicle control
|
identical to proprietary formulation of active eye drop but without active ingredient, sodium hyaluronate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
staining of the cornea and conjunctiva
Time Frame: Day 7
|
Day 7
|
symptom frequency score
Time Frame: Day 7
|
Day 7
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
staining of the cornea and conjunctiva
Time Frame: Day 14
|
Day 14
|
symptom frequency score
Time Frame: Day 14
|
Day 14
|
Quality of Life assessment
Time Frame: Day 7 and Day 14
|
Day 7 and Day 14
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Roger Vogel, MD, Rx Development Resources, LLC
- Study Director: Terry Laliberte, BS, River Plate Biotechnology, Inc.
- Principal Investigator: Charles (Andy) Kirby, MD, Chattanooga Eye Institute, Chattanooga, TN
- Principal Investigator: Mark Abrams, MD, Abrams Eye Center, Cleveland, OH
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RP-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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