Evaluation of Two Daily Disposable Contact Lenses.

NCT ID: NCT01300065

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 441 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-05-31

Brief Summary

The objective of this clinical study is to evaluate the product performance of SofLens daily disposable contact lenses packaged in the investigational Test solution versus SofLens daily disposable contact lenses packaged in Control, solution as it relates to comfort when used by subjects who use technology devices (eg, Personal Digital Assistants [PDAs], computers, electronic game consoles, hand-held electronic devices, electronic book readers, etc) on an average of 4 hours per day over a week's time for a minimum of 4 days each week.

Conditions

Myopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Experimental- Soflens

Bausch \& Lomb experimental soflens daily disposable contact lens packaged in an investigational storage solution.

Group Type: EXPERIMENTAL

Experimental- Soflens

Intervention Type: DEVICE

A new pair of lenses will be worn each day while the subject is in the study

Marketed - Soflens

Bausch \& Lomb daily disposable marketed soflens contact lens packaged with: 0.5% poloxamine in buffered saline solution.

Group Type: ACTIVE_COMPARATOR

Marketed - Soflens

Intervention Type: DEVICE

A new pair of lenses will be worn each day while the subject is in the study.

Interventions

Experimental- Soflens

A new pair of lenses will be worn each day while the subject is in the study

Intervention Type: DEVICE

Marketed - Soflens

A new pair of lenses will be worn each day while the subject is in the study.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
• Subjects must be free of any anterior segment disorders.
• Subjects must be adapted soft contact 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 willing and able to wear the study lenses for at least 8 hours (12 hours or more is recommended) each day throughout the duration of the study.
• Subjects must use a technologic device for an average of 4 hours per day over a week's time and at a minimum of 4 days per week.

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 corneal infiltrates, of ANY GRADE, are not eligible.
• 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 who have had any corneal surgery (eg, refractive surgery).
• Subjects who are allergic to any component in the study care products.
• Subjects may not use their habitual rewetting drops while participating in this study.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beverly J Barna, CCRA

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb Incorporated

Rochester, New York, United States

Countries

United States

Other Identifiers

642

Identifier Type: -

Identifier Source: org_study_id