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

Bausch + Lomb

Status: Completed

Conditions: Myopia

Treatments: Device: Marketed 1 Day Contact Lens; Device: SofLens Daily Disposable

Study type: Interventional

Funder types: Industry

Identifiers

NCT00902850

ROC2-08-169

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

SofLens Daily Disposable

Experimental group

Description:

SofLens Daily Disposable Lenses

Treatment:

Device: SofLens Daily Disposable

Marketed 1 Day Contact Lens

Active Comparator group

Description:

Marketed 1 Day Contact Lens

Treatment:

Device: Marketed 1 Day Contact Lens