Safety and Efficacy of a Contact Lens for Daily Disposable Use

NCT01365039 | Completed Results

• 1 other identifier: 690
• Study Type: interventional
• Target: 173
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to evaluate the safety and efficacy of a new hydrogel daily disposable contact lens compared to the Bausch + Lomb SofLens® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.

Conditions

Myopia

Keywords

contact lens

Outcome Measures

Primary Outcomes (2)

• Slit Lamp Findings > Grade 2

  Statistical non-inferiority of Slit Lamp Findings \> Grade 2 at any visit between the Test and Control lenses

  4 visits over 3 months

• High Contrast, Distance logMAR Visual Acuity (VA)

  Mean high contrast, distance logMAR VA for each eye between the Test and Control lenses. For each eye, logMAR VA will be averaged over all follow-up visits as the primary endpoint

  4 visits over 3 months

Study Arms (2)

Test lens

EXPERIMENTAL

Test contact lens will be worn on a daily disposable wear basis.

Device: Test, daily disposable contact lens

SofLens lens

ACTIVE COMPARATOR

The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.

Device: SofLens daily disposable contact lens

Interventions

Test, daily disposable contact lens DEVICE

Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.

Test lens

SofLens daily disposable contact lens DEVICE

Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.

SofLens lens

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must be myopic and require lens correction from -0.50 D to -6.00 D in each eye.
• Subjects must be correctable through spherocylindrical refraction to 40 logMAR letters or better (distance, high contrast) in each eye.
• Subjects must be free of any anterior segment disorders.
• Subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily disposable wear basis for approximately 3 months.

You may not qualify if:

• Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
• Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
• Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Subjects who have had any corneal surgery (eg, refractive surgery).
• Subjects who are allergic to any component in the study care products.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb, Inc.

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Robert Steffen, OD, MS
• Organization: Bausch & Lomb Incorporated

robert.steffen@bausch.com

(585) 338-6399

Study Officials

• Beverly Barna, CCRA

  Bausch & Lomb Incorporated

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 3, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: January 8, 2014
• Results First Posted: January 8, 2014

Record last verified: 2013-11

Locations

US (1)