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A Study to Evaluate a Modified Contact Lens

Primary Purpose

Myopia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

SofLens in investigational solution

SofLens in currently marketed solution

About this trial

This is an interventional treatment trial for Myopia focused on measuring ocular irritation

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Bausch & Lomb, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SofLens in investigational solution

SofLens in currently marketed solution

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Visual Acuity

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01391364

First Posted

June 16, 2011

Last Updated

September 9, 2020

Sponsor

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01391364

Brief Title

A Study to Evaluate a Modified Contact Lens

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myopia

Keywords

ocular irritation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

438 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SofLens in investigational solution

Arm Type

Experimental

Arm Description

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

Arm Title

SofLens in currently marketed solution

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

SofLens in investigational solution

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

SofLens in currently marketed solution

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Eyes With > Grade 2 Slit Lamp Findings

Description

Time Frame

At 2 weeks follow up

Title

Visual Acuity

Description

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

Time Frame

At 2 weeks follow up

Secondary Outcome Measure Information:

Title

Symptoms and Complaints

Description

Time Frame

At 2 weeks follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Bausch & Lomb, Inc.

City

Rochester

State/Province

New York

ZIP/Postal Code

14609

Country

United States

12. IPD Sharing Statement

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A Study to Evaluate a Modified Contact Lens

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