Safety and Efficacy of a Contact Lens for Daily Disposable Use

Myopia Clinical Trial

Official title:

A Study to Evaluate the Safety and Efficacy of a Novel Contact Lens for Daily Disposable Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365039
• Other study ID #: 690
• Status: Completed
• Phase: N/A
• First received: June 1, 2011
• Last updated: November 20, 2013
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: November 2013
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Test, daily disposable contact lens
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.
• SofLens daily disposable contact lens
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.

Locations

Country	Name	City	State
United States	Bausch & Lomb, Inc.	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No