Clinical Comparison of Two Silicone-Hydrogel Contact Lenses

NCT ID: NCT00762385

Last Updated: 2018-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2007-10-31

Brief Summary

The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.

Conditions

Refractive Error

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

galyfilcon A/comfilcon A

galyfilcon A first, comfilcon A second

Group Type: ACTIVE_COMPARATOR

galyfilcon A

Intervention Type: DEVICE

galyfilcon A

comfilcon A

Intervention Type: DEVICE

comfilcon A

comfilcon A/galyfilcon A

comfilcon A first, galyfilcon A second

Group Type: ACTIVE_COMPARATOR

galyfilcon A

Intervention Type: DEVICE

galyfilcon A

comfilcon A

Intervention Type: DEVICE

comfilcon A

Interventions

galyfilcon A

galyfilcon A

Intervention Type: DEVICE

comfilcon A

comfilcon A

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes.
• The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder.
• The subject, based on his/her knowledge, must be in good general health.
• The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations.
• Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear.
• Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
• Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period.
• The subject must read, indicate understanding of and sign the Informed Consent Form.

Exclusion Criteria

• The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.
• The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.
• The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)
• Slit lamp findings that would contraindicate contact lens wear such as:

• pathological dry eye or associated findings
• pterygium or corneal scars within the visual axis
• neovascularization equal to or greater than 1mm in from the limbus
• history of giant papillary conjunctivitis (GPC) worse than grade 2
• anterior uveitis or iritis (past or present)
• seborrhoeic eczema
• seborrhoeic conjunctivitis
• A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
• A known history of corneal hypoesthesia (reduced corneal sensitivity).
• Contact lens snellen visual acuities (VA) worse than 20/30.
• Aphakia, keratoconus or a highly irregular cornea.
• Current pregnancy or lactation (to the best of the subject's knowledge)
• Any active participation in another clinical study at any time during this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foresight Regulatory Strategies, Inc.

INDUSTRY

Sponsor Role: collaborator

Visioncare Research Ltd.

OTHER

Sponsor Role: collaborator

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CR-0713

Identifier Type: -

Identifier Source: org_study_id