Oasys vs. Extreme H20 Xtra 59 - Full Text View

Sponsored by:	Innovative Medical
Information provided by:	Innovative Medical
ClinicalTrials.gov Identifier:	NCT00477763

Purpose

To compare the performance of Oasys to Extreme H20 xtra 59 in dry eye contact lens pts who receive Restasis in 1 eye and vehicle (Endura) in the other eye.

Condition	Intervention	Phase
Dry Eye	Drug: Restasis, Refresh Endura	Phase IV

Drug Information available for: Cyclosporin Cyclosporine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Official Title:	Oasys vs. Extreme H20 Xtra 59

Further study details as provided by Innovative Medical:

Primary Outcome Measures:

comparing performance of contact lens [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Dry eye [ Time Frame: 10 months ] [ Designated as safety issue: No ]

Enrollment:	52
Study Start Date:	May 2007
Study Completion Date:	February 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Restasis, Refresh Endura Restasis 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening Refresh Endura 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening
2: Placebo Comparator	Drug: Restasis, Refresh Endura Restasis 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening Refresh Endura 0.4ml- (in the eye) instill twice daily in the randomized eye morning and evening

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or Female at least 19 years of age
Contact Lens Wearers
Patients with mild to moderate symptoms of dry eye

Exclusion Criteria:

male or female younger than 19 years of age

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477763

Locations

United States, Pennsylvania
Hazleton Eye Specialists
Hazleton, Pennsylvania, United States, 18202

Sponsors and Collaborators

Innovative Medical

Investigators

Principal Investigator:

Thomas Kislan, OD

Hazleton Eye Specialists

More Information

Responsible Party:	Hazleton Eye Specialists ( Thomas Kislan, OD )
Study ID Numbers:	5300
Study First Received:	May 21, 2007
Last Updated:	February 13, 2008
ClinicalTrials.gov Identifier:	NCT00477763
Health Authority:	Unitet States: Institutional Review Board

Study placed in the following topic categories:

Cyclosporine
Clotrimazole
Miconazole
Tioconazole
Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antifungal Agents
Physiological Effects of Drugs

Enzyme Inhibitors
Antirheumatic Agents
Immunosuppressive Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009