Evaluation of Comfilcon A and Senofilcon A Lenses

NCT ID: NCT01695369

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2012-08-31

Brief Summary

Evaluation of Comfilcon A and Senofilcon A Lenses

Detailed Description

Non-dispensing, single-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye.

Conditions

Myopia

Study Design

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

Study Groups

Senofilcon A

Senofilcon A; Comfilcon A

Group Type: ACTIVE_COMPARATOR

Senofilcon A; Comfilcon A

Intervention Type: DEVICE

Senofilcon A; Comfilcon A

Comfilcon A; Senofilcon A

Intervention Type: DEVICE

Comfilcon A; Senofilcon A

Comfilcon A

Comfilcon A; Senofilcon A

Group Type: EXPERIMENTAL

Senofilcon A; Comfilcon A

Intervention Type: DEVICE

Senofilcon A; Comfilcon A

Comfilcon A; Senofilcon A

Intervention Type: DEVICE

Comfilcon A; Senofilcon A

Interventions

Senofilcon A; Comfilcon A

Senofilcon A; Comfilcon A

Intervention Type: DEVICE

Comfilcon A; Senofilcon A

Comfilcon A; Senofilcon A

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

Subjects must satisfy the following conditions prior to inclusion in the study:

• Has had an oculo-visual examination in the last two years
• Is at least 18 years of age and has full legal capacity to volunteer
• Has read and understood the information consent letter
• Is willing and able to follow instructions and maintain the appointment schedule
• Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction
• Currently wears soft contact lenses at least 3 days a week, 8 hours a day
• Has clear corneas and no active ocular disease
• Has not worn lenses for at least 12 hours before the examination
• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

• No amblyopia
• No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes)
• No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
• No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)
• No aphakia
• Has prescription to match the available power range.

Exclusion Criteria

Any of the following will render a subject ineligible for inclusion:

• Greater than 0.75 of refractive astigmatism in either eye
• Has never worn contact lenses before
• Wears contact lenses on an extended wear basis
• Has any systemic disease affecting ocular health
• Is a known sufferer of ocular allergies
• Is taking medication, such as oral antihistamines, antihistamine eye drops, oral and ophthalmic beta-adrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, oral steroids and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
• Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities
• Is aphakic
• Has undergone corneal refractive surgery.
• Is wearing monovision
• Is participating in any other type of clinical or research study
• Female who is currently pregnant or is breast-feeding
• Has > grade 1 ocular corneal staining in both type and extent by > grade 2 in either type or extent

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

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Bergmanson, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Houston College of Optometry, TERTC

Locations

University of Houston College of Optometry, TERTC

Houston, Texas, United States

Countries

United States

Other Identifiers

CV-12-54

Identifier Type: -

Identifier Source: org_study_id