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

NCT ID: NCT01844388

Last Updated: 2019-04-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

365 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-29

Study Completion Date

2013-12-02

Brief Summary

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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

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Conditions

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Contact Lens Lubrication

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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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.

Group Type EXPERIMENTAL

carboxymethylcellulose based eye drop formula

Intervention Type DRUG

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®

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.

Group Type ACTIVE_COMPARATOR

carboxymethylcellulose sodium based eye drop solution

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type DRUG

Other Intervention Names

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REFRESH CONTACTS®

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Bloomington, Illinois, United States

Site Status

Countries

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United States

References

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Nichols JJ, Lievens CW, Bloomenstein MR, Liu H, Simmons P, Vehige J. Dual-Polymer Drops, Contact Lens Comfort, and Lid Wiper Epitheliopathy. Optom Vis Sci. 2016 Aug;93(8):979-86. doi: 10.1097/OPX.0000000000000878.

Reference Type BACKGROUND
PMID: 27254807 (View on PubMed)

Other Identifiers

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10077X-001

Identifier Type: -

Identifier Source: org_study_id

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