N/A N=86 Randomized Single-blind Treatment

Clinical Performance of a Monthly Replacement Silicone Hydrogel Lens

Refractive Errors

Bottom Line

View on ClinicalTrials.gov: NCT03586167 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Distance Visual Acuity (VA) — -0.09; -0.09 logMAR

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: LID014341 contact lenses (Device); Comfilcon A contact lenses (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Sep 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Distance Visual Acuity (VA)	-0.09; -0.09	—

Summary

The purpose of this study is to assess the clinical performance of an investigational, coated silicone hydrogel contact lens over approximately 30 days of daily wear.

Eligibility Criteria

Inclusion Criteria

Able to understand and sign an informed consent form approved by an Institutional review board (IRB);
Successful wear of spherical monthly replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months;
Best-corrected visual acuity (BCVA) 20/25 or better in each eye;
Willing to stop wearing habitual contact lenses for the duration of study participation.

Exclusion Criteria

Any conditions or use of medications that could contraindicate contact lens wear;
History of or plan to have refractive surgery in either eye;
Irregular cornea in either eye;
Ocular or intraocular surgery (excluding placement of punctal plugs) within the previous 12 months or planned during the study;
Current or history of intolerance, hypersensitivity or allergy to any component of the study products;
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;
Use of topical ocular medications and artificial tear or rewetting drops requiring instillation during contact lens wear;
Habitual Biofinity contact lens wearers.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03586167). 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.