A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-08-31

Brief Summary

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A study to evaluate the tolerability and acceptability of an investigational eye drop formulation 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

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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New Eye Drop Formulation then Systane®

1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks.

Group Type OTHER

Carboxymethylcellulose Sodium Based Eye Drops

Intervention Type DRUG

1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops \[New Eye Drop Formula\] in each eye.

Systane® Gel Drops

Intervention Type DRUG

1 to 2 drops of Systane® Gel Drops in each eye.

Systane® then New Eye Drop Formulation

1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks.

Group Type OTHER

Carboxymethylcellulose Sodium Based Eye Drops

Intervention Type DRUG

1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops \[New Eye Drop Formula\] in each eye.

Systane® Gel Drops

Intervention Type DRUG

1 to 2 drops of Systane® Gel Drops in each eye.

Genteal® then New Eye Drop Formulation

1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks.

Group Type OTHER

Carboxymethylcellulose Sodium Based Eye Drops

Intervention Type DRUG

1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops \[New Eye Drop Formula\] in each eye.

Genteal® Lubricant Gel Drops

Intervention Type DRUG

1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.

New Eye Drop Formulation then Genteal®

1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks.

Group Type OTHER

Carboxymethylcellulose Sodium Based Eye Drops

Intervention Type DRUG

1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops \[New Eye Drop Formula\] in each eye.

Genteal® Lubricant Gel Drops

Intervention Type DRUG

1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.

Interventions

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Carboxymethylcellulose Sodium Based Eye Drops

1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops \[New Eye Drop Formula\] in each eye.

Intervention Type DRUG

Systane® Gel Drops

1 to 2 drops of Systane® Gel Drops in each eye.

Intervention Type DRUG

Genteal® Lubricant Gel Drops

1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.

Intervention Type DRUG

Other Intervention Names

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1 to 2 drops of Systane® Gel Drops in each eye daily.

Eligibility Criteria

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Inclusion Criteria

* Current use of an artificial tear product
* Visual Acuity of at least 20/40 (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), photorefractive keratectomy within 6 months
* Use of RESTASIS® Cyclosporine Ophthalmic Emulsion or any topical cyclosporine within 3 months
* Diagnosis of glaucoma.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No