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

Not Applicable

Completed

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

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Subjective Rating for Comfort.	2-weeks - End of Day	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Vision Quality	2 weeks - End of Day	Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)
Surface Deposits	2-weeks	Surface deposits is assessed. (Scale 0-4,0.25 steps) (0=no deposits; 1 = \<5 deposits; 2 = \>5 deposits or film 25-50% of surface; 3 = deposits 0.1 - 0.5mm or film 50-75% of surface; 4 = deposits \>0.5mm or film \> 75% of surface)
Lens Handling (Ease of Insertion)	2 weeks	Lens handling - ease of insertion of the lenses. Scale 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye.
Lens Handling (Ease of Removal)	2 weeks	Lens handling - ease of removal of the lenses. Scale 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye.
Subjective Preference for Comfort.	2 weeks	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever
Lens Surface Wettability	2 weeks	Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)

Secondary Outcome Measures

Name	Time	Method

Locations (2): Center for Contact Lens Research, University of Waterloo
🇨🇦
Waterloo, Ontario, Canada
Clinical Research Center, University of California, Berkeley
🇺🇸
Berkeley, California, United States