A Study to Compare a New Eye Drop Formulation With Refresh Contacts®

Allergan

Status and phase: Completed; Phase 3

Conditions: Contact Lens Lubrication

Treatments: Drug: carboxymethylcellulose sodium based eye drop solution; Drug: carboxymethylcellulose based eye drop formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT01844388

10077X-001

Details and patient eligibility

About

This study will compare the safety and efficacy of a new carboxymethylcellulose based eye drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.

Enrollment: 365 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-Adapted contact wearer with daily usage of at least 6 hours a day, 5 days a week.

Exclusion criteria

• Wearing monovision lenses
• Have had refractive surgery within the previous 12 months
• Have infection of the eye, eyelids or eye structures.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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365 participants in 2 patient groups

Carboxymethylcellulose Based Eye Drop Formula

Experimental group

Description:

1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.

Treatment:

Drug: carboxymethylcellulose based eye drop formula

REFRESH CONTACTS®

Active Comparator group

Description:

1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.

Treatment:

Drug: carboxymethylcellulose sodium based eye drop solution