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

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

Study Overview

• Status: Completed
• Conditions: Myopia; Hyperopia
• Intervention / Treatment: Device: senofilcon A; Device: Sapphire

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Center for Contact Lens Research, University of Waterloo
• United States
  • California
    • Berkeley, California, United States, 94704
      • Clinical Research Center, University of California, Berkeley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sapphire; Participants were randomized to wear the Sapphire lens pair for two weeks during the cross over study.	Device: Sapphire; silicone-hydrogel contact lens
Active Comparator: senofilcon A; Participants were randomized to wear the senofilcon A lens pair for two weeks during the cross over study.	Device: senofilcon A; contact lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vision Quality	Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)	Baseline (10 minutes post lens settling at dispense)
Vision Quality	Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)	2 weeks - During the Day
Vision Quality	Subjective rating for vision quality. Collected at dispense after settling of each study pair. (0-100 scale; 0=extremely poor vision, 100=excellent vision)	2 weeks - End of Day
Subjective Rating for Comfort.	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever	Baseline - 10 minutes post lens settling
Subjective Rating for Comfort.	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever	2-weeks - During the Day
Subjective Rating for Comfort.	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever	2-weeks - End of Day
Lens Surface Wettability	Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)	Baseline (10 minutes post lens settling)
Lens Surface Wettability	Lens surface wettability assessed. Scale 0-4, 0.25 steps, 0=nonwetting, 4=excellent)	2 weeks
Surface Deposits	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)	Baseline (10 minutes post lens settling)
Surface Deposits	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)	2-weeks
Lens Handling (Ease of Insertion)	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.	2 weeks
Lens Handling (Ease of Removal)	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.	2 weeks
Subjective Preference for Comfort.	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever	Baseline - 10 minutes post lens settling
Subjective Preference for Comfort.	Subjective rating for comfort. Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever	2 weeks

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Meng Lin, OD PhD, University of California, Berkeley; Principal Investigator: Lyndon Jones, PhD FCO, University of Waterloo CCLR

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 14, 2015
• First Submitted That Met QC Criteria: January 19, 2015
• First Posted (Estimate): January 26, 2015

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: August 25, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Hyperopia
• Other Study ID Numbers: CV-15-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes