A Study to Evaluate a Modified Contact Lens

A Study to Evaluate the Product Performance of a Modified Contact Lens

This study is being conducted to evaluate the product performance of SofLens daily disposable contact lenses packaged in an investigational Test solution versus SofLens daily disposable contact lenses packaged in the currently marketed solution (Control), as it relates to comfort when worn by adapted soft contact lens wearers on a daily-wear basis.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: SofLens in investigational solution; Device: SofLens in currently marketed solution

• Study Type: Interventional
• Enrollment (Actual): 438
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14609
      • Bausch & Lomb, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must be free of any anterior segment disorders.
• Subjects must be adapted 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 habitual wearers of daily disposable or planned replacement (at least every 3 months) soft contact lenses.
• Subjects must live/work in an urban environment at least 6 hours per day and for at least 4 days per week throughout the duration of the study.
• Subjects must be willing and able to wear the study lenses on a daily wear basis while in an urban environment.
• Subjects living/working in the urban environment must feel challenged by harsh, drying outdoor conditions (ie dust, pollution, smog).
• Subjects must feel that being in an urban environment has a negative effect on their lens wearing experience.
• Subjects must have access to an internet connection and be able to send and receive email.

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 any grade 2 or greater finding during the slit lamp examination
• 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 with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
• Subjects who are allergic to any component in the study care products.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SofLens in investigational solution; Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution.	Device: SofLens in investigational solution; SofLens in investigational solution, worn on a daily disposable basis for 7 days.
Active Comparator: SofLens in currently marketed solution; SofLens daily disposable contact lens packaged in currently marketed storage solution.	Device: SofLens in currently marketed solution; SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Acuity	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).	At 2 weeks follow up
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.	At 2 weeks follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms and Complaints	Symptoms and complaints were assessed on a scale from 0 to 100, with 0 denoting the most unfavorable symptoms/complaints. Symptoms/complaints were collected by eye from each participant and based on the participant's experience with the study lenses. Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, and Overall impression.	At 2 weeks follow up

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: June 16, 2011
• First Submitted That Met QC Criteria: July 8, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Actual): September 30, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: ocular irritation
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Pharmaceutical Solutions
• Other Study ID Numbers: 691