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Refractive Surgery and Optive Compatibility Study

NCT ID: NCT00469157

Last Updated: 2008-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-04-30

Brief Summary

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

Detailed Description

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Conditions

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Dry Eye Syndromes

Keywords

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compatibility of Optive after PRK or LASIK

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1.

Group Type OTHER

Optive

Intervention Type DRUG

Optive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery

Interventions

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Optive

Optive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovative Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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TLC

Principal Investigators

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Loren Rude, OD

Role: PRINCIPAL_INVESTIGATOR

TLC

Locations

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TLC

Fullerton, California, United States

Site Status

Countries

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United States

Other Identifiers

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5303

Identifier Type: -

Identifier Source: org_study_id