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Oasys vs. Extreme H20 Xtra 59

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ClinicalTrials.gov Identifier: NCT00477763
Recruitment Status : Completed
First Posted : May 24, 2007
Last Update Posted : February 18, 2008
Sponsor:
Information provided by:
Innovative Medical

Brief Summary:
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 or disease Intervention/treatment Phase
Dry Eye Drug: Restasis, Refresh Endura Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Oasys vs. Extreme H20 Xtra 59
Study Start Date : May 2007
Actual Primary Completion Date : February 2008
Actual Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. comparing performance of contact lens [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. Dry eye [ Time Frame: 10 months ]


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Thomas Kislan, OD, Hazleton Eye Specialists
ClinicalTrials.gov Identifier: NCT00477763     History of Changes
Other Study ID Numbers: 5300
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: February 18, 2008
Last Verified: February 2008

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