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

Allergan

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndromes

Treatments: Drug: Genteal® Lubricant Gel Drops; Drug: Carboxymethylcellulose Sodium Based Eye Drops; Drug: Systane® Gel Drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT02455050

11193X-002

Details and patient eligibility

About

A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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79 participants in 4 patient groups

New Eye Drop Formulation then Systane®

Other group

Description:

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.

Treatment:

Drug: Systane® Gel Drops

Drug: Carboxymethylcellulose Sodium Based Eye Drops

Systane® then New Eye Drop Formulation

Other group

Description:

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.

Treatment:

Drug: Systane® Gel Drops

Drug: Carboxymethylcellulose Sodium Based Eye Drops

Genteal® then New Eye Drop Formulation

Other group

Description:

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.

Treatment:

Drug: Carboxymethylcellulose Sodium Based Eye Drops

Drug: Genteal® Lubricant Gel Drops

New Eye Drop Formulation then Genteal®

Other group

Description:

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.

Treatment:

Drug: Carboxymethylcellulose Sodium Based Eye Drops

Drug: Genteal® Lubricant Gel Drops