Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

This study has been completed.

First Received on November 28, 2006. Last Updated on February 19, 2010 History of Changes

Sponsor:	Innovative Medical
Information provided by:	Innovative Medical
ClinicalTrials.gov Identifier:	NCT00405457

Purpose

To evaluate the efficacy, safety and tolerability of a combination of Optive® Artificial Tears with Restasis®.The primary hypothesis is that the Ocular Surface Disease Index (OSDI) score and symptoms will be the same or lower than baseline after treatment in these patients. The patients will tolerate the combination of Restasis® and Optive® with a low incidence of clinical adverse events.

Condition	Intervention	Phase
Dry Eye	Drug: Restasis, Optive Tears	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms

Resource links provided by NLM:

Drug Information available for: Cyclosporine Cyclosporin

U.S. FDA Resources

Further study details as provided by Innovative Medical:

Primary Outcome Measures:

efficacy [ Time Frame: 1 yr 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

dry eye symptoms [ Time Frame: 1 yr 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	November 2006
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A	Drug: Restasis, Optive Tears Restasis and Optive Tears use twice daily more frequently if needed

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

· Males or females > 18 years old
- Patients currently taking Restasis® for at least 3 months in duration and using artificial tears as needed for dry eye.
- Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

· Patients using Restasis® for less than 3 months.
- Known contraindications to any study medication or ingredients
- Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
- Other active uncontrolled ocular diseases or uncontrolled systemic disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405457

Locations

United States, Minnesota
Minnesota Eye Consultants
Minneapolis, Minnesota, United States, 55404

Sponsors and Collaborators

Innovative Medical

Investigators

Principal Investigator:

David Hardten, MD

Minnesota Eye Consultants

More Information

No publications provided

Responsible Party:	David Hardten, MD, Minnesota Eye Consultants
ClinicalTrials.gov Identifier:	NCT00405457 History of Changes
Other Study ID Numbers:	5261
Study First Received:	November 28, 2006
Last Updated:	February 19, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporins
Cyclosporine

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012