A Bilateral Dispensing Comparison of Comfilcon A Over Senofilcon C Contact Lenses

A Bilateral Dispensing Comparison of Biofinity Toric and Acuvue Vita for Astigmatism

The aim of this study is to evaluate the subjective acceptance of Comfilcon A contact lenses when worn on a daily wear modality over one month.

Study Overview

• Status: Completed
• Conditions: Astigmatism Bilateral
• Intervention / Treatment: Device: Comfilcon A (test); Device: Senofilcon C (control)

Detailed Description

This study is a 30-subjects prospective, double-masked (investigator and participant), bilateral, randomized, one month cross-over dispensing study comparing subject acceptance of Comfilcon A against Senofilcon A contact lenses.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years and older (Child, 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 he/she:

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has had a self-reported oculo-visual examination in the last two years.
3. Has read and signed an information consent letter;
4. Is willing and able to follow instructions and maintain the appointment schedule;
5. Is an adapted soft contact lens wearer, who currently wears contact lenses for a minimum 3 days/week and 8 hours/day AND who anticipates no difficulty wearing CLs for 6 days/week, 10 hours /day.
6. Is willing to wear contact lens in both eyes for the duration of the study;
7. Has a minimum astigmatism of - 0.75, determined by refraction;
8. Can be fit with the two study contact lens types in the powers available;
9. Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
10. Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
11. Has clear corneas and no active* ocular disease;

Exclusion Criteria:

A person will be excluded from the study if he/she:

1. Is participating in any concurrent clinical trial;
2. Has any known active* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study measure;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
5. Has known sensitivity to fluorescein dye or products to be used in the study;
6. Appears to have any active* ocular pathology, ocular anomaly or severe insufficiency of lacrimal secretion (severe dry eye) that would affect the wearing of contact lenses;
7. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
8. Is aphakic;
9. Has undergone refractive error surgery;
10. Has participated in the previous QUENA study.

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
Active Comparator: Comfilcon A (test); Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.	Device: Comfilcon A (test); Daily wear contact lenses; Device: Senofilcon C (control); Daily wear contact lenses
Active Comparator: Senofilcon C (control); Participants were randomized to wear either test or control contact lenses bilaterally for one month during the cross-over study.	Device: Comfilcon A (test); Daily wear contact lenses; Device: Senofilcon C (control); Daily wear contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Insertion(Handling)	Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)	Baseline
Ease of Insertion (Handling)	Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)	2 weeks
Ease of Insertion(Handling)	Subjective ratings of ease of insertion for each pair of lenses (scale: 0-10; 0= Very difficult,10 = Very easy)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotational Recovery After Lens Mislocation	Lens relocation after 10 blinks, after 30º rotation mislocation	Baseline
Rotational Recovery After Lens Mislocation	Lens relocation after 10 blinks, after 30º rotation mislocation.	1 month

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Lyndon Jones, PhD FCOptom, Director, Centre for Ocular Research and Education

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2018
• Primary Completion (Actual): December 14, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-94

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