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Refractive Surgery and Optive Compatibility Study

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.
 
ClinicalTrials.gov Identifier: NCT00469157
Recruitment Status : Completed
First Posted : May 4, 2007
Last Update Posted : April 17, 2008
Sponsor:
Information provided by:
Innovative Medical

Brief Summary:
To assess the compatibility of Optive with refractive surgery (PRK and LASIK) post-operatively.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Optive Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Refractive Surgery and Optive Compatibility Study
Study Start Date : May 2007
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Arm Intervention/treatment
1. Drug: Optive
Optive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery




Primary Outcome Measures :
  1. Assess compatibility [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. comfort [ Time Frame: 8 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women 18 and over
  • Patients undergoing refractive surgery

Exclusion Criteria:

  • Concurrent ocular conditions or pathology that could affect patient's ability to complete study
  • Concurrent use of topical medications other than study medications
  • Use of systemic medications with ocular drying sequelae:

    • Antihistamines
    • Decongestants
    • Antispasmotics
    • Antidepressants

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): NCT00469157


Locations
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United States, California
TLC
Fullerton, California, United States, 92831
Sponsors and Collaborators
Innovative Medical
Investigators
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Principal Investigator: Loren Rude, OD TLC
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Responsible Party: Loren Rude, OD, TLC
ClinicalTrials.gov Identifier: NCT00469157    
Other Study ID Numbers: 5303
First Posted: May 4, 2007    Key Record Dates
Last Update Posted: April 17, 2008
Last Verified: April 2008
Keywords provided by Innovative Medical:
compatibility of Optive after PRK or LASIK
Additional relevant MeSH terms:
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Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases