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

NCT ID: NCT01077011

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Brief Summary

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

Detailed Description

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Conditions

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Dry Eye

Keywords

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Dry eye artificial tears

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lubricant eye drop

Lubricant eye drop

Group Type EXPERIMENTAL

Lubricant eye drop FID 115958D

Intervention Type OTHER

1 drop in each eye, one time

GenTeal Gel

GenTeal Gel

Group Type ACTIVE_COMPARATOR

GenTeal Gel

Intervention Type OTHER

1 drop in each eye, one time

Interventions

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Lubricant eye drop FID 115958D

1 drop in each eye, one time

Intervention Type OTHER

GenTeal Gel

1 drop in each eye, one time

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

References

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

Reference Type RESULT

Other Identifiers

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C-09-060

Identifier Type: -

Identifier Source: org_study_id