A Safety and Efficacy Study of Refresh Optive® Gel Drops in Patients With Dry Eye Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-13

Study Completion Date

2015-03-16

Brief Summary

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This study will evaluate the safety and efficacy o fRefresh Optive® Gel Drops in patients with dry eye disease.

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Detailed Description

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Conditions

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Dry Eye Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Refresh Optive® Gel Drops

Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Group Type EXPERIMENTAL

Refresh Optive® Gel Drops

Intervention Type DRUG

Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

REFRESH LIQUIGEL®

REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Group Type ACTIVE_COMPARATOR

REFRESH LIQUIGEL®

Intervention Type DRUG

REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Interventions

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Refresh Optive® Gel Drops

Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Intervention Type DRUG

REFRESH LIQUIGEL®

REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Current use of an artificial tear product
* Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion Criteria

* Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
* Cataract surgery, laser-assisted in situ keratomileusis \[LASIK\], or photorefractive keratectomy, within the last 6 months
* Current eye infection or inflammation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No