Clinical trial NCT02345811: A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks
Official title: A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 34
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Vision Quality
timeFrame: Baseline (10 minutes post lens settling at dispense)
measure: Vision Quality
timeFrame: 2 weeks - During the Day
measure: Vision Quality
timeFrame: 2 weeks - End of Day
measure: Subjective Rating for Comfort.
timeFrame: Baseline - 10 minutes post lens settling
measure: Subjective Rating for Comfort.
timeFrame: 2-weeks - During the Day
measure: Subjective Rating for Comfort.
timeFrame: 2-weeks - End of Day
measure: Lens Surface Wettability
timeFrame: Baseline (10 minutes post lens settling)
measure: Lens Surface Wettability
timeFrame: 2 weeks
measure: Surface Deposits
timeFrame: Baseline (10 minutes post lens settling)
measure: Surface Deposits
timeFrame: 2-weeks
measure: Lens Handling (Ease of Insertion)
timeFrame: 2 weeks
measure: Lens Handling (Ease of Removal)
timeFrame: 2 weeks
measure: Subjective Preference for Comfort.
timeFrame: Baseline - 10 minutes post lens settling
measure: Subjective Preference for Comfort.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Clinical Research Center, University of California, Berkeley
state: California
city: Waterloo
country: Canada
facility: Center for Contact Lens Research, University of Waterloo
state: Ontario
Study officials:
affiliation: University of California, Berkeley
name: Meng Lin, OD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Waterloo CCLR
name: Lyndon Jones, PhD FCO
role: PRINCIPAL_INVESTIGATOR
References: