A Clinical Evaluation of an Investigational Lubricant Eye... | NCT01294956

Studies
A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)

NCT01294956

Sponsor

Alcon Research

Status

Completed

Last Update Posted

Nov 18, 2016Estimated

Enrollment

147Actual

Phase

Not Applicable

Conditions

Dry Eye

Interventions

Lubricant Eye Drop
Refresh Liquigel

Countries

Not provided

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

Jan 2012

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

Jan 2011

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Feb 10, 2011

First Submission Date that Met QC Criteria

Feb 11, 2011

First Posted Date

Feb 14, 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

Nov 17, 2016

Last Update Posted Date

Nov 18, 2016Estimated

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 estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

147Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FID 115958D	Experimental	Lubricant Eye Drop	Other: Lubricant Eye Drop
Refresh Liquigel	Active Comparator	Lubricant Eye Drop	Other: Refresh Liquigel

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lubricant Eye Drop	Other	1 drop in each eye, four times a day for 42 days	FID 115958D

Measure	Description	Time Frame
Corneal Staining		Day 42

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Documented diagnosis of dry eye
NaFl Corneal staining sum score ≥ 3 in either eye
Current use of a lubricant eye gel or ointment at least once per week (over the previous month)

Exclusion Criteria:

No contact lenses wear throughout the study period
Must not have had punctal plugs inserted within 30 days preceding enrollment

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24403819	Result	Cohen S, Martin A, Sall K. Evaluation of clinical outcomes in patients with dry eye disease using lubricant eye drops containing polyethylene glycol or carboxymethylcellulose. Clin Ophthalmol. 2014;8:157-64. doi: 10.2147/OPTH.S53822. Epub 2013 Dec 31.

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

ID	Term
D065346	Lubricant Eye Drops
D002266	Carboxymethylcellulose Sodium

ID	Term
D009883	Ophthalmic Solutions
D019999	Pharmaceutical Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations