Expired Study
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Overland Park, Kansas


Purpose:

This study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following LASIK surgery


Criteria:

Inclusion Criteria: - Patient is scheduled for bilateral LASIK surgery - Patient is in good general health - Eye glasses prescription of -1 to -8 Exclusion Criteria: - Significant Dry Eye - Presence of eye disease - Uncontrolled systemic disease


Study is Available At:


Original ID:

192371-014


NCT ID:

NCT00611403


Secondary ID:


Study Acronym:


Brief Title:

Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients


Official Title:

Safety and Efficacy Study of Cyclosporine Ophthalmic Emulsion in Post-LASIK Patients


Overall Status:

Active, not recruiting


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

21 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Allergan


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

80


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Medical Director
Study Director
Allergan

Study Dates

Start Date:December 2007
Completion Date:April 2009
Completion Type:Anticipated
Primary Completion Date:January 2009
Primary Completion Type:Anticipated
Verification Date:January 2009
Last Changed Date:January 13, 2009
First Received Date:January 28, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Schirmer tear test
Time Frame:Months 1-6
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:contrast sensitivity
Time Frame:Months 1-6
Safety Issues:False
Outcome Type:Primary Outcome
Measure:corneal sensitivity
Time Frame:Month 3
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
Description:Cyclosporine Ophthalmic Emulsion 0.05% administered twice daily in each eye for 6 months following LASIK surgery
Arm Name:1
Intervention Type:Drug
Name:Artificial Tears REFRESH ENDURA®
Description:REFRESH ENDURA® administered twice daily in each eye for 6 months following LASIK surgery
Arm Name:2

Study Arms

Study Arm Type:Active Comparator
Arm Name:1
Study Arm Type:Placebo Comparator
Arm Name:2

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Allergan

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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