A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks

CooperVision

Status: Completed

Conditions: Myopia; Hyperopia

Treatments: Device: Sapphire; Device: senofilcon A

Study type: Interventional

Funder types: Industry

Identifiers

NCT02345811

CV-15-01

Details and patient eligibility

About

To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.

Full description

This was a randomized, bilateral, 2 week cross over, double-masked, dispensing study comparing Sapphire test lens against the senofilcon A control lens. This study results were not used to support design validation of the test lens.

Enrollment: 34 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer
• Has read and signed an information consent letter
• Is willing and able to follow instructions and maintain the appointment schedule;
• Is an adapted soft contact lens wearer
• Requires spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)
• Has no more than 0.75 diopters of refractive astigmatism
• Willing to wear contact lens in both eyes
• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye
• To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable

Exclusion criteria

• Is participating in any concurrent clinical or research study
• Has any known active* ocular disease and/or infection
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
• Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit)
• Is aphakic
• Has undergone refractive error surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Sapphire

Experimental group

Description:

Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study.

Treatment:

Device: Sapphire

senofilcon A

Active Comparator group

Description:

Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study.

Treatment:

Device: senofilcon A