Study of Cyclosporine in the Treatment of Dry Eye Syndrom... | NCT00549289

Studies
Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-006)

NCT00549289

Sponsor

Sirion Therapeutics, Inc.

Status

Completed

Last Update Posted

Oct 25, 2007Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Dry Eye Syndromes

Interventions

cyclosporine A

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

Oct 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

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 24, 2007

First Submission Date that Met QC Criteria

Oct 24, 2007

First Posted Date

Oct 25, 2007Estimated

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

Oct 24, 2007

Last Update Posted Date

Oct 25, 2007Estimated

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 3

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
cyclosporine A	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of dry eye syndrome

Exclusion Criteria:

Intraocular or refractive surgery in the study eye within 3 months prior to study start
Unwilling to discontinue use of contact lenses during the study
Pregnancy or lactation

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Roger Vogel	Sirion Therapeutics	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Clayton Eye Center		Morrow	Georgia	30260	United States

ID	Term
D015352	Dry Eye Syndromes

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

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