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

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: SofLens Daily Disposable; Device: Marketed 1 Day Contact Lens

• Registration Number: NCT00902850
• Lead Sponsor: Bausch & Lomb Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2009-05-14
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Status Verified: 2015-02
• Results First Submitted: 2015-02-13
• Results First Submitted QC: 2015-02-13
• Last Update Submitted: 2015-02-13
• Results First Posted: 2015-03-02
• Last Update Posted: 2015-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SofLens Daily Disposable	SofLens Daily Disposable	SofLens Daily Disposable Lenses
Marketed 1 Day Contact Lens	Marketed 1 Day Contact Lens	Marketed 1 Day Contact Lens

Primary Outcome Measures

Name	Time	Method
Clinical Performance	Insertion, 4 hours & End of Day	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.

Trial Locations

Locations (1)

Bausch & Lomb Research Clinic; 🇺🇸 Rochester, New York, United States