Efficacy of Topical Cyclosporine Versus Tears for Improvi... | NCT00349583

Studies
Efficacy of Topical Cyclosporine Versus Tears for Improving Visual Outcomes Following Multifocal IOL Implantation

NCT00349583

Sponsor

Innovative Medical

Status

Completed

Last Update Posted

Jun 1, 2007Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Cataract
Dry Eye

Interventions

Topical Cyclosporine, Tears

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

May 2007

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

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

May 30, 2007

Last Update Posted Date

Jun 1, 2007Estimated

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy on quality of vision and dry eye signs and symptoms in patients undergoing cataract surgery using the ReZoom® multifocal IOL.

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

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Topical Cyclosporine, Tears	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

· Males or females > 50 years old
- Scheduled to undergo bilateral phacoemulsification with implantation of a multifocal IOL.
- Likely to complete all study visits and able to provide informed consent
- Visual potential of 20/25 or better

Exclusion Criteria:

· Prior use of topical cyclosporine
- Known contraindications to any study medication or ingredients
- Active ocular diseases or uncontrolled systemic disease
- Active ocular allergies

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 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
Eric Donnenfeld, MD	Ophthalmic Consultants of Long Island	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmic Consultants of Long Island		Rockville Centre	New York	11570	United States

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases
D007766	Lacrimal Apparatus 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