We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oasys vs. Extreme H20 Xtra 59

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00477763
First Posted: May 24, 2007
Last Update Posted: February 18, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Innovative Medical
  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 (Participant, Investigator)
Official Title: Oasys vs. Extreme H20 Xtra 59

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Thomas Kislan, OD, Hazleton Eye Specialists
ClinicalTrials.gov Identifier: NCT00477763     History of Changes
Other Study ID Numbers: 5300
First Submitted: May 21, 2007
First Posted: May 24, 2007
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