Completed

NCT Number: NCT03139812

Daily Irrigation With Silicone Hydrogel Contact Lens Continuous Wear

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.

Completed

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Key information

Conditions

Corneal Epithelial Permeability

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Daily irrigation

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

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

30-day SiH CW

Device

30-day continuous wear of silicone hydrogel contact lenses

Primary outcomes

Corneal epithelial permeability (Pdc) at Baseline

Time frame: Baseline

Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec at baseline with no contact lenses
Corneal epithelial permeability (Pdc) Post-1-Day CW

Time frame: Post-1-Day CW of SiH contact lenses

Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 1 night of contact lens CW
Corneal epithelial permeability (Pdc) Post-30-Day CW

Time frame: Post-30-Day CW of SiH contact lenses

Rate of fluorescein clearance through the corneal epithelium, measured by scanning fluorometry, in nm/sec after 30 nights of contact lens CW
Risk of adverse events

Time frame: Post-30-day CW of SiH contact lenses

Odds ratios (OR) for adverse events: contact lens-induced, mechanically-induced, inflammatory, and overall

Sponsors and collaborators

Lead sponsor

University of California, Berkeley

Other

Registry information

Official study title

Effects of Daily Irrigation on Corneal Epithelial Permeability and Adverse Events With Silicone Hydrogel Contact Lens Continuous Wear

Acronym: EW23

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: May 4, 2017
Registry last updated: May 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.