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OpenTrials
Completed

NCT Number: NCT01391364

A Study to Evaluate 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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch & Lomb, Inc.

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SofLens in investigational solution

Device

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

SofLens in currently marketed solution

Device

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

Primary outcomes

  1. Percentage of Eyes With > Grade 2 Slit Lamp Findings

    Time frame: At 2 weeks follow up

    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. Visual Acuity

    Time frame: At 2 weeks follow up

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

Secondary outcomes

  1. Symptoms and Complaints

    Time frame: At 2 weeks follow up

    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.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 12, 2011
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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