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Refractive Surgery and Optive Compatibility Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00469157
First Posted: May 4, 2007
Last Update Posted: April 17, 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 assess the compatibility of Optive with refractive surgery (PRK and LASIK) post-operatively.

Condition Intervention Phase
Dry Eye Syndromes Drug: Optive Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Refractive Surgery and Optive Compatibility Study

Resource links provided by NLM:


Further study details as provided by Innovative Medical:

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

Secondary Outcome Measures:
  • comfort [ Time Frame: 8 months ]

Enrollment: 92
Study Start Date: May 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1. Drug: Optive
Optive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  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): NCT00469157


Locations
United States, California
TLC
Fullerton, California, United States, 92831
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: Loren Rude, OD TLC
  More Information

Responsible Party: Loren Rude, OD, TLC
ClinicalTrials.gov Identifier: NCT00469157     History of Changes
Other Study ID Numbers: 5303
First Submitted: May 2, 2007
First Posted: May 4, 2007
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:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases