Daily Irrigation With Silicone Hydrogel Contact Lens Continuous Wear (EW23)

University of California (UC), Berkeley

Status and phase: Completed; Phase 4

Conditions: Corneal Epithelial Permeability

Treatments: Device: 30-day SiH CW; Drug: Daily irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT03139812

UCBCRCEW23

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 161 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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161 participants in 2 patient groups

30-day SiH CW, No Daily Irrigation

Other group

Description:

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

Treatment:

Device: 30-day SiH CW

30-day SiH CW, Daily Irrigation

Other group

Description:

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

Treatment:

Device: 30-day SiH CW

Drug: Daily irrigation