A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: lotrafilcon B; Device: comfilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01952665

EX-MKTG-41

Details and patient eligibility

About

A Multi-Center Study Comparing the Clinical Performance of Two Silicone Hydrogel Lenses Over 1 Month of Daily Wear

Full description

Two-month, single masked, randomized, bilateral, crossover, 1-month of daily wear in each study lens.

Enrollment: 63 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is between 18 and 40 years of age (inclusive)
• Have the use of a mobile phone to send and receive text messages throughout the day for the duration of the study
• Has had a self-reported visual exam in the last two years
• Is an adapted soft CL wearer
• Has a Contact Lens (CL) spherical prescription between - 1.00 and - 9.00 (inclusive)
• Has less than 0.75D spectacle cylinder in each eye
• Is correctable to a visual acuity of 20/25 or better in both eyes
• Has clear corneas and no active ocular disease
• Has read, understood and signed the information consent letter
• Is willing to comply with the wear schedule (at least 40 hrs per week)
• Is willing to comply with the visit schedule

Exclusion criteria

• Has never worn contact lenses before
• Currently wears rigid gas permeable contact lenses
• Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
• Has a contact lens prescription outside the range of - 1.00 to -9.00D
• Has a spectacle cylinder greater than -0.50D of cylinder in either eye
• Has best corrected spectacle distance vision worse then 20/25 in either eye
• Has any systemic disease affecting ocular health
• Is using any systemic or topical medications that will affect ocular health
• Has any ocular pathology or severe insufficiency of lacrimal secretion
• Has persistent, clinically significant corneal or conjunctival staining
• Has active neovascularization or any central corneal scars
• Is aphakic
• Is presbyopic
• Has undergone corneal refractive surgery
• Is participating in any other type of eye related clinical or research study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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63 participants in 2 patient groups

comfilcon A

Active Comparator group

Description:

Daily wear soft contact lens comfilcon A

Treatment:

Device: lotrafilcon B

lotrafilcon B

Active Comparator group

Description:

Daily wear soft contact lens lotrafilcon B

Treatment:

Device: comfilcon A