Study to Evaluate a Contact Lens Lubricating and Rewetting Drop

NCT ID: NCT01267656

Last Updated: 2020-09-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2010-12-31

Brief Summary

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The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.

Detailed Description

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Conditions

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Dry Eye

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Participants

Study Groups

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Lubricating and Rewetting Drops

Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.

Group Type EXPERIMENTAL

Lubricating and Rewetting Drops

Intervention Type DEVICE

Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.

AMO Blink Contacts Lubricant Eye Drops

AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week

Group Type ACTIVE_COMPARATOR

AMO Blink Contacts Lubricant Eye Drops

Intervention Type DEVICE

Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.

Interventions

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Lubricating and Rewetting Drops

Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.

Intervention Type DEVICE

AMO Blink Contacts Lubricant Eye Drops

Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
* Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
* Use a lens care system on a regular basis.
* Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.
* Willing to use drops 4 times per day.

Exclusion Criteria

* Participating in a conflicting study.
* An active ocular disease, any corneal infiltrative response, or are using any ocular medications.
* Any scar or neovascularization within the central 4mm of the cornea.
* Any grade 2 or greater finding during the slit lamp examination
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* Aphakic.
* Amblyopic.
* Allergic to any component in the study care products.
* Have had any corneal surgery.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Su, OD

Role: PRINCIPAL_INVESTIGATOR

Bausch & Lomb Incorporated

Locations

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Bausch & Lomb

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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684E

Identifier Type: -

Identifier Source: org_study_id

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