Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms - Full Text View

Sponsor:	Innovative Medical
Information provided by:	Innovative Medical
ClinicalTrials.gov Identifier:	NCT00399061

Purpose

The purpose of this study is to evaluate the efficacy of Optive versus Systane used concomitantly with topical cyclosporine for the treatment of dry eye.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Efficacy of Optive Versus Systane 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: 1yr 3 months ] [ Designated as safety issue: No ]

Enrollment:	55
Study Start Date:	November 2006
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Systane	Drug: Systane, Optive, Restasis Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed
Active Comparator: 2 Optive	Drug: Systane, Optive, Restasis Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening more frequently if needed
Placebo Comparator: 3 Restasis	Drug: Systane, Optive, Restasis Systane 30ml (in the eye) instill one drop twice a day in morning and evening Optive 15ml (in the eye) instill one drop twice a day in morning and evening Restasis 0.4ml (in the eye) instill one drop twice a day in morning and evening 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
- Score of at least 2 and no more than 4 on the SESOD at the initial screening visit (mild to severe patients)
- At least Grade 2 conjunctival staining
- Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

· Prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements)
- Current use of topical cyclosporine
- 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.
- Planned use of contact lenses (unless discontinued use ³ 30 days prior to randomization)
- Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
- Ocular surgery within the past 3 months,
- Active ocular allergies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00399061

Locations

United States, New York
Dr. Schultze
Slingerlands, New York, United States, 12159

Sponsors and Collaborators

Innovative Medical

Investigators

Principal Investigator:

Robert Schultze, MD

Slingerlands Medical Building

More Information

No publications provided

Responsible Party:	Robert Schultze, MD, Slingerlands Medical Building
ClinicalTrials.gov Identifier:	NCT00399061 History of Changes
Other Study ID Numbers:	5278
Study First Received:	November 9, 2006
Last Updated:	September 23, 2008
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