NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for... | NCT00739349

Studies
NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye

NCT00739349

Sponsor

Santen SAS

Status

Completed

Last Update Posted

Jun 6, 2016Estimated

Enrollment

132Actual

Phase

Phase 2

Conditions

Dry Eye

Interventions

NOVA22007 ''Cyclosporine''
NOVA22007 ''Cyclosporine''
vehicle/placebo

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

Jun 2015

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

Aug 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Aug 20, 2008

First Submission Date that Met QC Criteria

Aug 20, 2008

First Posted Date

Aug 21, 2008Estimated

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

Apr 29, 2015

Certification/Extension First Submitted that Passed QC Review

Apr 29, 2015

Certification/Extension First Posted Date

May 18, 2015Estimated

Last Update Submitted Date

May 26, 2016

Last Update Posted Date

Jun 6, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Study is to assess the safety and efficacy of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Cationic Emulsions QD compared to vehicle for the treatment of the signs and symptoms of dry eye after a 3 month treatment period.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Cyclosporine 0.05%	Drug: NOVA22007 ''Cyclosporine''
2	Experimental	Cyclosporine 0.1%	Drug: NOVA22007 ''Cyclosporine''
3	Placebo Comparator	vehicle/placebo	Drug: vehicle/placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NOVA22007 ''Cyclosporine''	Drug	Cyclosporine 0.05% Ophthalmic Cationic Emulsions	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the safety and efficacy of two doses of NOVA22007 0.05% and 0.1% Cyclosporine Ophthalmic Emulsions		Approximately 13 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and female 18 years and older
Diagnosis of dry eye in both eyes

Exclusion Criteria:

Contraindications to the use of the study medications
Known allergy or sensitivity to the study medications or their components
Female currently pregnant, nursing, or planning a pregnancy; or woman who has a positive pregnancy test
Have participated in an investigational drug or device study within 30 days of Visit 1

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Maine Eye Care, PA		Lewiston	Maine	04240	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