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Refractive Surgery and Optive Compatibility Study

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Optive
Sponsored by
Innovative Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dry Eye Syndromes focused on measuring compatibility of Optive after PRK or LASIK

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TLC

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1.

Arm Description

Outcomes

Primary Outcome Measures

Assess compatibility

Secondary Outcome Measures

comfort

Full Information

First Posted
May 2, 2007
Last Updated
April 16, 2008
Sponsor
Innovative Medical
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1. Study Identification

Unique Protocol Identification Number
NCT00469157
Brief Title
Refractive Surgery and Optive Compatibility Study
Official Title
Refractive Surgery and Optive Compatibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Innovative Medical

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
Keywords
compatibility of Optive after PRK or LASIK

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1.
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Optive
Intervention Description
Optive 30ml- (in the eye) Instill one in each eye twice daily starting one week after surgery
Primary Outcome Measure Information:
Title
Assess compatibility
Time Frame
8 months
Secondary Outcome Measure Information:
Title
comfort
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loren Rude, OD
Organizational Affiliation
TLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
TLC
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States

12. IPD Sharing Statement

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Refractive Surgery and Optive Compatibility Study

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