Daily Irrigation With Silicone Hydrogel Contact Lens Continuous Wear

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-15

Study Completion Date

2012-10-15

Brief Summary

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This study sought to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens continuous wear (CW) could improve ocular surface integrity and reduce the risk of adverse events.

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Detailed Description

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The purpose of this study was to determine whether daily irrigation with sterile saline solution during silicone hydrogel (SiH) contact lens 30-day continuous wear (CW) can mitigate increases in corneal epithelial permeability (Pdc) and reduce the risk of mechanical, contact lens-induced, inflammatory, and overall adverse events. 161 non-contact lens wearers were fit with SiH contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day CW. Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.

Conditions

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Corneal Epithelial Permeability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

161 non-contact lens wearers were fit with silicone hydrogel (SiH) contact lenses and randomized to either a treatment (n = 81) or control (n = 80) group for 30-day continuous wear (CW). Subjects in the treatment group irrigated every morning and whenever dryness symptoms occurred; subjects in the control group did not.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Research optometrists conducting eye examinations and technicians conducting fluorometry measurements did not know whether a given subject was in the treatment (irrigating) or control (non-irrigating) group.

Study Groups

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30-day SiH CW, No Daily Irrigation

Control group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines with no daily morning irrigation of the eyes with sterile saline solution

Group Type OTHER

30-day SiH CW

Intervention Type DEVICE

30-day continuous wear of silicone hydrogel contact lenses

30-day SiH CW, Daily Irrigation

Treatment group subjects wore SiH lenses for 30-day CW under normal clinical practice guidelines, and also irrigated the eyes with sterile saline solution every morning upon awakening

Group Type OTHER

Daily irrigation

Intervention Type DRUG

Daily morning irrigation of the eye with sterile, borate-buffered, saline solution (Unisol 4) and gentle nudging of the lens to promote solution flow beneath the lens

30-day SiH CW

Intervention Type DEVICE

30-day continuous wear of silicone hydrogel contact lenses

Interventions

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Daily irrigation

Daily morning irrigation of the eye with sterile, borate-buffered, saline solution (Unisol 4) and gentle nudging of the lens to promote solution flow beneath the lens

Intervention Type DRUG

30-day SiH CW

30-day continuous wear of silicone hydrogel contact lenses

Intervention Type DEVICE

Other Intervention Names

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Unisol 4 (Alcon Laboratories, Inc., Fort Worth, TX)

Eligibility Criteria

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Inclusion Criteria

* spectacle prescriptions between -1.00 diopter sphere (DS) and -10.00 DS;
* less than 0.75 diopters (D) of astigmatism;
* free of any ocular disease or systemic disease with ocular manifestation;

Exclusion Criteria

* history of contact lens wear within the past year;
* history of ocular surgery or serious injury;
* presence of corneal scarring;
* frequent swimming, smoking, or use of medications w/ ocular side effects;

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes