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Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Lubricant Eye Gel

Primary Purpose

Dry Eye

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Lubricant eye drop FID 115958D

GenTeal Gel

About this trial

This is an interventional treatment trial for Dry Eye focused on measuring Dry eye, artificial tears

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Documented diagnosis of dry eye

Exclusion Criteria:

Must not have worn contact lenses within 12 hours preceding enrollment
Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lubricant eye drop

GenTeal Gel

Arm Description

Lubricant eye drop

GenTeal Gel

Outcomes

Primary Outcome Measures

Three-minute visual blur profile

Overall Acceptability

Secondary Outcome Measures

Drop Comfort Upon Instillation

Full Information

NCT ID

NCT01077011

First Posted

February 18, 2010

Last Updated

November 18, 2016

Sponsor

Alcon Research

1. Study Identification

Unique Protocol Identification Number

NCT01077011

Brief Title

Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Lubricant Eye Gel

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alcon Research

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to compare the comfort and blurriness of an investigational lubricant eye drop with a marketed lubricant eye gel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye

Keywords

Dry eye, artificial tears

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lubricant eye drop

Arm Type

Experimental

Arm Description

Lubricant eye drop

Arm Title

GenTeal Gel

Arm Type

Active Comparator

Arm Description

GenTeal Gel

Intervention Type

Other

Intervention Name(s)

Lubricant eye drop FID 115958D

Intervention Description

1 drop in each eye, one time

Intervention Type

Other

Intervention Name(s)

GenTeal Gel

Intervention Description

1 drop in each eye, one time

Primary Outcome Measure Information:

Title

Three-minute visual blur profile

Time Frame

Through 3 minutes (post-instillation)

Title

Overall Acceptability

Time Frame

Immediately upon instillation

Secondary Outcome Measure Information:

Title

Drop Comfort Upon Instillation

Time Frame

Immediately upon installation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Documented diagnosis of dry eye Exclusion Criteria: Must not have worn contact lenses within 12 hours preceding enrollment Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment

12. IPD Sharing Statement

Citations:

Citation

http://www.aaopt.org/evaluation-efficacy-and-patient-acceptance-new-lubricant-eye-gel

Results Reference

result

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Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Lubricant Eye Gel

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