A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens

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

This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens.

The study results were not used for design validation of the investigational product.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Sapphire contact lenses; Device: senofilcon A contact lenses

Detailed Description

This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Campbell, California, United States, 95008
      • Family Eye Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A person is eligible for inclusion in the study if they:

  1. Are at least 18 years of age and have full legal capacity to volunteer;
  2. Have read and signed an information consent letter;
  3. Are willing and able to follow instructions and maintain the appointment schedule;
  4. Are an adapted soft contact lens wearer;

  5. Require spectacle lens powers in both eyes;

     1. Sphere: between -1.75 to -6.00 diopters and
     2. Astigmatism: between -1.00 to -2.25 and
     3. Axis: 180 ± 20 degrees
  6. Are willing to wear contact lenses in both eyes;
  7. Have manifest refraction visual acuities (VA) equal to or better than logMAR (log of the minimum angle of resolution) equivalent of 20/25 in each eye;
  8. 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 including toric orientation as acceptable.

Exclusion Criteria:

• A person will be excluded from the study if they:

  1. Are participating in any concurrent clinical or research study;
  2. Have any known active* ocular disease and/or infection;
  3. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  4. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
  5. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  6. Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
  7. Are aphakic;
  8. Have undergone refractive error surgery;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sapphire contact lenses; Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.	Device: Sapphire contact lenses; Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair
ACTIVE_COMPARATOR: senofilcon A; Each subject randomized to wear either the Investigational lenses (test) or senofilcon A contact lenses (control) as a matched pair and cross over to the second matched pair.	Device: senofilcon A contact lenses; Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Ratings for Comfort	Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)	Baseline (10 minutes post lens settling)
Subjective Ratings for Comfort	Scale 0-100; (0=Cannot be worn; 100=Cannot be felt ever)	2 weeks
Subjective Ratings for Comfort Preference	Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference	Baseline (10 minutes post lens settling)
Subjective Ratings for Comfort Preference	Subjective Ratings for Comfort Preference: Sapphire lens, senofilcon A lens, No preference	2 weeks
Subjective Assessment of Visual Quality	Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)	Baseline (10 minutes post lens settling)
Subjective Assessment of Visual Quality	Subjective assessment of visual quality assessed on a Scale: 0-100 (0=Extremely poor vision all of the time; Cannot function; 100=Excellent vision all of the time)	2 weeks
Subjective Assessment of Overall Satisfaction	Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)	Baseline (10 minutes post lens settling)
Subjective Assessment of Overall Satisfaction	Subjective assessment of overall satisfaction on a Scale: 0-100: (0=Extremely dissatisfied; 100=Extremely satisfied)	2 weeks
Subjective Overall Preference	Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference	Baseline (10 minutes post lens settling)
Subjective Overall Preference	Subjective Overall Preference: Sapphire lens, senofilcon A lens, No preference	2 weeks

Collaborators and Investigators

• Sponsor: Coopervision, Inc.
• Investigators: Principal Investigator: Michel Guillon, Ocular Technology Group

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (ACTUAL): February 1, 2016
• Study Completion (ACTUAL): April 1, 2016

Study Registration Dates

• First Submitted: September 4, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (ESTIMATE): September 21, 2015

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

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