One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens

Bausch & Lomb Incorporated28 enrolled

Overview

The objective of this one-day study will be to evaluate the clinical performance of SofLens Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Myopia

Interventions

SofLens Daily DisposableDEVICE

Lenses to be worn for 8-16 hours

Marketed 1 Day Contact LensDEVICE

Lenses to be worn for 8-16 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. * Have no active ocular disease or allergic conjunctivitis. * Not be using any topical ocular medications. Exclusion Criteria: * Participating in a conflicting study. * Considered by the Investigator to not be a suitable candidate for participation.

Locations (1)

Bausch & Lomb Research Clinic

Rochester, New York, United States

Outcomes

Primary Outcomes

Clinical Performance

Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness.

Time frame: Insertion, 4 hours & End of Day

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.