Safety and Efficacy Assessment of Vismed® (Sodium Hyaluronate) for the Treatment of Dry Eye Syndrome

NCT00599716 | Completed Phase 3

• 1 other identifier: RP-001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 10

Brief Summary

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®.

Conditions

Dry Eye Disease

Keywords

dry eye syndrome; dry eye disease; Vismed; dry eye; sodium hyaluronate; hyaluronic acid

Outcome Measures

Primary Outcomes (2)

• staining of the cornea and conjunctiva

  Day 7

• symptom frequency score

  Day 7

Secondary Outcomes (3)

• staining of the cornea and conjunctiva

  Day 14

• symptom frequency score

  Day 14

• Quality of Life assessment

  Day 7 and Day 14

Study Arms (2)

1

EXPERIMENTAL

study drug

Drug: sodium hyaluronate

2

PLACEBO COMPARATOR

vehicle control

Drug: vehicle

Interventions

sodium hyaluronate DRUG

a sterile, unpreserved eye drop containing sodium hyaluronate in a proprietary formulation to be administered by ocular instillation

Also known as: Vismed®, hyaluronic acid

1

vehicle DRUG

identical to proprietary formulation of active eye drop but without active ingredient, sodium hyaluronate

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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.

You may not qualify if:

• 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®.

Sponsors & Collaborators

• Lantibio: lead
• River Plate Biotechnology, Inc.: collaborator
• Rx Development Resources, LLC: collaborator

Study Sites (10)

Florida Eye Microsurgical Institute

Boynton Beach, Florida, 33426, United States

Location

Center for Excellence in Eye Care

Miami, Florida, 33176, United States

Location

East Florida Eye Institutue

Stuart, Florida, 34994, United States

Location

Abrams Eye Center

Stuart, Florida, 44115, United States

Location

International Eye Center

Tampa, Florida, 33603, United States

Location

American Eye Institute

New Albany, Indiana, 47150, United States

Location

Comprehensive Eye Care

Washington, Missouri, 63090, United States

Location

Charlotte Eye, Ear, Nose and Throat

Charlotte, North Carolina, 28210, United States

Location

Ophthalmic Research & Clinical Studies

Moon Twp, Pennsylvania, 15108, United States

Location

Chattanooga Eye Institute

Chattanooga, Tennessee, 37411, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Roger Vogel, MD

  Rx Development Resources, LLC

  STUDY CHAIR

• Terry Laliberte, BS

  River Plate Biotechnology, Inc.

  STUDY DIRECTOR

• Charles (Andy) Kirby, MD

  Chattanooga Eye Institute, Chattanooga, TN

  PRINCIPAL INVESTIGATOR

• Mark Abrams, MD

  Abrams Eye Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 11, 2008
• First Posted: January 24, 2008
• Study Start: December 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: May 1, 2008
• Last Updated: January 9, 2009

Record last verified: 2009-01

Locations

US (10)