Effect of FID 114675A on Lens Wettability

NCT ID: NCT01342107

Last Updated: 2012-04-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.

Detailed Description

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Conditions

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Contact Lens Wettability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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FID 114675A

Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to one eye, with contact lens removed directly from the blister pack assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours.

Group Type EXPERIMENTAL

FID 114675A multi-purpose disinfecting solution (MPDS)

Intervention Type DEVICE

Investigational multi-purpose disinfecting solution intended for use as a cleaning, reconditioning, rinsing, disinfecting, and storage solution for silicone hydrogel and soft contact lenses.

Soft contact lens

Intervention Type DEVICE

Soft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense.

Blister Pack

Contact lens removed directly from the blister pack randomly assigned to one eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours.

Group Type ACTIVE_COMPARATOR

Soft contact lens

Intervention Type DEVICE

Soft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense.

Blister pack solution

Intervention Type DEVICE

Commercially approved storage solution as found in the contact lens blister pack.

Interventions

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FID 114675A multi-purpose disinfecting solution (MPDS)

Investigational multi-purpose disinfecting solution intended for use as a cleaning, reconditioning, rinsing, disinfecting, and storage solution for silicone hydrogel and soft contact lenses.

Intervention Type DEVICE

Soft contact lens

Soft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense.

Intervention Type DEVICE

Blister pack solution

Commercially approved storage solution as found in the contact lens blister pack.

Intervention Type DEVICE

Other Intervention Names

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Acuvue2 PureVision Acuvue Oasys Acuvue2 PureVision Acuvue Oasys

Eligibility Criteria

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Inclusion Criteria

* 18 years or age or older with normal eyes, other than correction for refractive error.
* At least 5 days successful daily wear (minimum 8 hours per day) of PureVision®, Acuvue® Oasys™, or Acuvue® 2 contact lenses prior to Visit 1
* Vision correctable to 20/30 (Snellen) or better in each eye at distance with lenses at Visit 1 (Day 0 - Baseline).
* Grade 0 or Grade 1 wettability in both eyes after at least 15 minutes of lens wear at Visit 1 (Day 0 - Baseline).

Exclusion Criteria

* Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of the study.
* Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
* Use of products other than a multi-purpose solution or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to Visit 1 (Day 0 - Baseline).
* Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Use of lens rewetting drops is acceptable.
* History or current ocular infections or ocular inflammatory events.
* Ocular surgery within the past year.
* Participation in any investigational study within the past 30 days.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-10-024

Identifier Type: -

Identifier Source: org_study_id

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