Efficacy of Cyclosporine for the Prevention and Treatment... | NCT00349440

Studies
Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy

NCT00349440

Sponsor

Innovative Medical

Status

Completed

Last Update Posted

Sep 26, 2008Estimated

Enrollment

93Actual

Phase

Phase 4

Conditions

Dry Eye Syndromes

Interventions

Cyclosporine, Refresh Plus

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jul 5, 2006

First Submission Date that Met QC Criteria

Jul 5, 2006

First Posted Date

Jul 7, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2008

Last Update Posted Date

Sep 26, 2008Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the effect of topical cyclosporine ophthalmic solution 0.05% (Restasis, Allergan) on the signs and symptoms of dry eye in patients undergoing LASIK or photorefractive keratectomy (PRK).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

93Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: Cyclosporine, Refresh Plus
2	Placebo Comparator		Drug: Cyclosporine, Refresh Plus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyclosporine, Refresh Plus	Drug	Cyclosporine 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily. Refresh Plus 0.4ml (in the eye) on for 3 months instill one drop in randomized eye twice daily.

Measure	Description	Time Frame
Dry Eye Symptoms		1.5 years

Measure	Description	Time Frame
Dry eye signs		1.5 yrs

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males or females > 18 years old
Mild-moderate symptoms of dry eye prior to surgery
Scheduled to undergo bilateral LASIK or PRK
Likely to complete all study visits and able to provide informed consent

Exclusion Criteria:

Prior use of topical cyclosporine within the last 1 year
Known contraindications to any study medication or ingredients
Female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females.
Ocular disorders
Active ocular diseases or uncontrolled systemic disease
Active ocular allergies

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karl Stonecipher, MD	Southeastern Laser and Refractive Surgery	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southeastern Laser and Refractive Surgery		Greensboro	North Carolina	27410	United States

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016572	Cyclosporine

Ancestor Terms

ID	Term
D003524	Cyclosporins
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided