Refractive Surgery and Optive Compatibility Study

This study has been completed.
Information provided by:
Innovative Medical Identifier:
First received: May 2, 2007
Last updated: April 16, 2008
Last verified: April 2008

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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • comfort [ Time Frame: 8 months ] [ Designated as safety issue: No ]

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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Please refer to this study by its identifier: NCT00469157

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

No publications provided

Responsible Party: Loren Rude, OD, TLC Identifier: NCT00469157     History of Changes
Other Study ID Numbers: 5303
Study First Received: May 2, 2007
Last Updated: April 16, 2008
Health Authority: United States: Institutional Review Board

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
Conjunctival Diseases
Corneal Diseases processed this record on April 17, 2014