Clinical trial NCT03139812: Daily Irrigation With Silicone Hydrogel Contact Lens Continuous Wear
Official title: Effects of Daily Irrigation on Corneal Epithelial Permeability and Adverse Events With Silicone Hydrogel Contact Lens Continuous Wear
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Corneal Epithelial Permeability
Keywords: continuous contact lens wear
silicone hydrogel contact lenses
irrigation
corneal epithelial permeability
contact lens-related adverse events
Lead sponsor: University of California, Berkeley
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Corneal epithelial permeability (Pdc) at Baseline
timeFrame: Baseline
measure: Corneal epithelial permeability (Pdc) Post-1-Day CW
timeFrame: Post-1-Day CW of SiH contact lenses
measure: Corneal epithelial permeability (Pdc) Post-30-Day CW
timeFrame: Post-30-Day CW of SiH contact lenses
measure: Risk of adverse events
timeFrame: Post-30-day CW of SiH contact lenses
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Berkeley
name: Meng C Lin, OD, PhD, FAAO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lin MC, French HM, Graham AD, Sanders TL. Effects of daily irrigation on corneal epithelial permeability and adverse events with silicone hydrogel contact lens continuous wear. Invest Ophthalmol Vis Sci. 2014 Feb 10;55(2):776-83. doi: 10.1167/iovs.13-13508.