Refractive Surgery and Optive Compatibility Study

This study has been completed.

Sponsored by:	Innovative Medical
Information provided by:	Innovative Medical
ClinicalTrials.gov Identifier:	NCT00469157

Purpose

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

Condition	Intervention	Phase
Dry Eye Syndromes	Drug: Optive	Phase IV

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Refractive Surgery and Optive Compatibility Study

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:

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

Criteria

Inclusion Criteria:

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 ClinicalTrials.gov identifier: 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:	TLC ( Loren Rude, OD )
Study ID Numbers:	5303
Study First Received:	May 2, 2007
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00469157
Health Authority:	United States: Institutional Review Board

Keywords provided by Innovative Medical:

compatibility of Optive after PRK or LASIK

Study placed in the following topic categories:

Eye Diseases
Lacrimal Apparatus Diseases
Dry Eye Syndromes

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on January 16, 2009