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Oasys vs. Extreme H20 Xtra 59

This study has been completed.
Sponsor:
Information provided by:
Innovative Medical
ClinicalTrials.gov Identifier:
NCT00477763
First received: May 21, 2007
Last updated: February 13, 2008
Last verified: February 2008
History of Changes
  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 4

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

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

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

No publications provided

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

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

ClinicalTrials.gov processed this record on June 17, 2013