Altaire Gel Forming Solution Versus Refresh Tears for the... | NCT01382810

Studies
Altaire Gel Forming Solution Versus Refresh Tears for the Treatment of Dry Eye Signs and Symptoms

NCT01382810

Sponsor

Innovative Medical

Status

Unknown status

Last Update Posted

Jun 14, 2012Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Dry Eye Syndromes

Interventions

Altaire Gel forming solution
Refresh 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

Jun 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Oct 2012Estimated

Completion Date

Oct 2012Estimated

First Submitted Date

Jun 24, 2011

First Submission Date that Met QC Criteria

Jun 24, 2011

First Posted Date

Jun 27, 2011Estimated

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

Jun 13, 2012

Last Update Posted Date

Jun 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The purpose of this study is to evaluate and compare the effects of Altaire Gel forming solution and Refresh Tears in mild-moderate dry eye patients.

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

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Altaire Gel forming solution	Active Comparator		Drug: Altaire Gel forming solution
Refresh Tears	Placebo Comparator		Drug: Refresh Tears

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Altaire Gel forming solution	Drug	Three times a day for two months	Altaire Gel forming solution

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
TBUT	Test performed that measures how long the tears take to break up	2 months
Conjunctival and Corneal staining	Dye that will be placed inside the eye to evaluate the surface of the ey	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients 18 years or older.
Males or females.
Patient reported dry eye symptoms (episodic, annoying, activity limiting).
Physician assessment of mild-moderate dry eye.
Patient willing to instill drops TID and complete entire length of protocol.
TBUT _< 10 seconds.
At least Grade 6 Corneal Staining.

Exclusion Criteria:

Current topical cyclosporine use (Restasis)
Current Refresh use.
Refractive surgery within the last 6 months.
Oral or topical corticosteroid use.
Severe dry eye patients by physician assessment.
Current active blepharitis.
Oral doxycycline use.
Oral antihistamine use.

Accepts Healthy Volunteers

Yes

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

Name	Role	Phone	Extension	Email
Jenna Piel	Contact	951-653-5566		j.piel@imedsonline.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jackson Eye, SC	Recruiting	Lake Villa	Illinois		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