A Study to Evaluate a Modified Contact Lens

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391364
• Other study ID #: 691
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: July 2011

Study information

• Verified date: September 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: July 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

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

Locations

Country	Name	City	State
United States	Bausch & Lomb, Inc.	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Visual Acuity	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).	At 2 weeks follow up
Secondary	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