N/A N=119 Randomized Double-blind Treatment

Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

Refractive Errors

Bottom Line

View on ClinicalTrials.gov: NCT03920280 ↗

Enrolled (actual)

119

Serious AEs

0.2%

Results posted

Feb 2022

Primary outcome: Primary: Distance Visual Acuity (VA) With Study Lenses - Completed Eyes — -0.06; -0.06; -0.06; -0.05 logMAR

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: LID015385 contact lenses (Device); Comfilcon A soft contact lenses (Device); CLEAR CARE (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Oct 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Distance Visual Acuity (VA) With Study Lenses - Completed Eyes	-0.06; -0.06; -0.06; -0.05; -0.06; -0.06	—
PRIMARY Distance Visual Acuity (VA) With Study Lenses - Discontinued Eyes	-0.04; -0.06; -0.02; -0.06; -0.04; -0.05	—

Summary

The purpose of this clinical study is to demonstrate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Eligibility Criteria

Key Inclusion Criteria

Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
Manifest cylinder ≤ 0.75 diopter (D) in each eye.
Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria

Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
Monovision contact lens wearers.
Habitually wearing Biofinity® lenses.
Other protocol-specified exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03920280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.