Evaluation of Two Daily Disposable Contact Lenses.

A Study to Evaluate the Product Performance of Two Daily Disposable Contact Lenses

The objective of this clinical study is to evaluate the product performance of SofLens daily disposable contact lenses packaged in the investigational Test solution versus SofLens daily disposable contact lenses packaged in Control, solution as it relates to comfort when used by subjects who use technology devices (eg, Personal Digital Assistants [PDAs], computers, electronic game consoles, hand-held electronic devices, electronic book readers, etc) on an average of 4 hours per day over a week's time for a minimum of 4 days each week.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Experimental- Soflens; Device: Marketed - Soflens

• Study Type: Interventional
• Enrollment (Actual): 441
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch & Lomb Incorporated

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) 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 wear a lens in each eye and each lens must be of the same manufacture and brand.
• Subjects must be myopic and require contact lens correction from -0.50 D to -6.00 D in each eye.
• Subjects must be willing and able to wear the study lenses for at least 8 hours (12 hours or more is recommended) each day throughout the duration of the study.
• Subjects must use a technologic device for an average of 4 hours per day over a week's time and at a minimum of 4 days per week.

Exclusion Criteria:

• Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
• 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 an active ocular disease or who are using any ocular medication.
• Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
• Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Subjects with any scar or neovascularization within the central 4 mm of the cornea.
• Subjects who have had any corneal surgery (eg, refractive surgery).
• Subjects who are allergic to any component in the study care products.
• Subjects may not use their habitual rewetting drops while participating in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental- Soflens; Bausch & Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution.	Device: Experimental- Soflens; A new pair of lenses will be worn each day while the subject is in the study
Active Comparator: Marketed - Soflens; Bausch & Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution.	Device: Marketed - Soflens; A new pair of lenses will be worn each day while the subject is in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Eyes With > Grade 2 Slit Lamp Findings	Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). The outcome measure is any finding > grade 2, across abnormalities.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial Lens Performance Survey	A lens performance survey was given to each participant at the Screening/Dispensing Visit, three minutes following insertion of the study lenses. Lens performance was assessed by eye for the following parameters: burning/stinging upon insertion, comfort upon insertion, ease of handling/insertion, vision upon insertion, and lens cleanness upon insertion. As with symptoms/complaints, responses were on a scale from 0 to 100, with 0 being the most unfavorable score.	At dispensing

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: February 17, 2011
• First Submitted That Met QC Criteria: February 17, 2011
• First Posted (Estimate): February 21, 2011

Study Record Updates

• Last Update Posted (Actual): October 6, 2020
• Last Update Submitted That Met QC Criteria: September 11, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: contact lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 642