A Study to Evaluate a Modified Contact Lens

NCT01391364 | Completed Results

• 1 other identifier: 691
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Keywords

ocular irritation

Outcome Measures

Primary Outcomes (2)

• 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

• Visual Acuity

  Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

  At 2 weeks follow up

Secondary Outcomes (1)

• Symptoms and Complaints

  At 2 weeks follow up

Study Arms (2)

SofLens in investigational solution

EXPERIMENTAL

Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution.

Device: SofLens in investigational solution

SofLens in currently marketed solution

ACTIVE COMPARATOR

SofLens daily disposable contact lens packaged in currently marketed storage solution.

Device: SofLens in currently marketed solution

Interventions

SofLens in investigational solution DEVICE

SofLens in investigational solution, worn on a daily disposable basis for 7 days.

SofLens in investigational solution

SofLens in currently marketed solution DEVICE

SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.

SofLens in currently marketed solution

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

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: Study Director
• Organization: Bausch Health

robert.steffen@bausch.com

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: July 12, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 30, 2020
• Results First Posted: September 30, 2020

Record last verified: 2020-09

Locations

US (1)