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

Phase 3

Completed

• Conditions: Contact Lens Lubrication
• Interventions: Drug: carboxymethylcellulose based eye drop formula; Drug: carboxymethylcellulose sodium based eye drop solution

• Registration Number: NCT01844388
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-29
• Study First Submitted QC: 2013-04-29
• Study First Posted: 2013-05-01
• Study Start: 2013-05-29
• Primary Completion: 2013-12-02
• Study Completion: 2013-12-02
• Results First Submitted: 2014-09-25
• Results First Submitted QC: 2014-09-25
• Results First Posted: 2014-09-29
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carboxymethylcellulose Based Eye Drop Formula	carboxymethylcellulose based eye drop formula	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.
REFRESH CONTACTS®	carboxymethylcellulose sodium based eye drop solution	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline	Baseline, Day 90	Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.