A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

NCT ID: NCT01873846

Last Updated: 2019-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2013-07-31

Brief Summary

The objective of this study is to evaluate the product performance of a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Silicone Hydrogel Contact Lens

Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.

Group Type: EXPERIMENTAL

Silicone Hydrogel Contact Lens

Intervention Type: DEVICE

Interventions

Silicone Hydrogel Contact Lens

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 have clear central corneas and 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 lens correction from -0.25 D to -6.00 D in each eye.
• Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week.
• Subjects must spend at least 3 hours each workday using a computer or electronic device (ie, smartphones, tablets, eReaders).
• Subjects must habitually wear soft contact lens.
• Subject must have no active ocular disease or allergic conjunctivitis.
• Subject must not be using any topical ocular medications.
• Subjects must be bothered (occasionally or frequently) by blurriness or fluctuations in vision with their current contact lenses.
• Subjects must habitually use a lens care product for cleaning, disinfection, and storage.

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 who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
• Subjects who are presbyopic or currently wear monovision, multifocal, or toric contact lenses.
• Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
• Subjects with anisometropia (spherical equivalent) of 2.00 D or greater in either eye.
• Subjects with any Grade 2 or greater finding during the slit lamp examination.
• 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 are aphakic.
• Subjects who are amblyopic.
• Subjects who have had any corneal surgery (eg, refractive surgery).
• Subjects who are allergic to any component in the study care products.
• Subjects who are bothered by blurriness or fluctuations in vision due to itchy eyes, something on or under the lens, allergies, or cigarette smoke.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson Varughese

Role: STUDY_DIRECTOR

Valeant Pharmaceuticals

Locations

Bausch & Lomb Incorporated

Madison, New Jersey, United States

Countries

United States

Other Identifiers

817

Identifier Type: -

Identifier Source: org_study_id