Comparison of Comfilcon A Toric Contact Lenses and Samfilcon A Toric Contact Lenses

A Bilateral Dispensing Comparison of Biofinity Toric and Ultra for Astigmatism

The objective of this study is to evaluate the subjective acceptance of comfilcon A toric contact lens, compared to samfilcon A toric lens.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: comfilcon A toric lens; Device: samfilcon A toric lens

• Study Type: Interventional
• Enrollment (Actual): 49
• 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: 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 and has full legal capacity to volunteer;
• Has had a self-reported oculo-visual examination in the last two years.
• 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, 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.
• Is willing to wear contact lens in both eyes for the duration of the study;
• Has a minimum astigmatism of - 0.75, determined by refraction;
• Can be fit with the two study contact lens types in the powers available;
• Has a distance visual acuity of 0.20 logMAR (approx 20/30) or better, determined by refraction;
• Can achieve a distance visual acuity of 0.20 logMAR (approx 20/30) or better in each eye with the study contact lenses.
• Has clear corneas and no active* ocular disease

Exclusion Criteria:

• Is participating in any concurrent clinical trial;
• Has any known active* ocular disease and/or infection;
• Has a systemic condition that in the opinion of the investigator may affect a study measure;
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study measure;
• Has known sensitivity to fluorescein dye or products to be used in the study;
• 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;
• 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.
• Has participated in the PIANO (i.e. EX-MKTG-83) 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
Experimental: comfilcon A toric lens; Subjects who wear comfilcon A toric lens either as first or second pair during this cross-over study.	Device: comfilcon A toric lens; Contact lens; Other Names: test lens; Biofinity toric; Device: samfilcon A toric lens; Contact lens; Other Names: Ultra for Astigmatism; control lens
Active Comparator: samfilcon A toric lens; Subjects who wear samfilcon A toric lens either as first or second pair during this cross-over study.	Device: comfilcon A toric lens; Contact lens; Other Names: test lens; Biofinity toric; Device: samfilcon A toric lens; Contact lens; Other Names: Ultra for Astigmatism; control lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comfort at Insertion	Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)	Dispense
Comfort	Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)	2 weeks
Comfort	Subjective ratings of comfort for each pair of lenses (scale: 0-10; 0=painful,10=can't feel lens)	1-month
Lens Preference Based on Overall Comfort	Lens preference with respect to comfort (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)	1 month
Lens Preference Based on Overall Dryness	Lens preference with respect to dryness (Prefer pair-1 strongly, Prefer pair-1 slightly, Prefer pair-2 strongly, prefer pair-2 slightly, No preference)	1 month
Dryness	Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)	2 weeks
Dryness	Subjective ratings of dryness for each pair of lenses (scale: 0-10; 0=Extremely dry, 10=No dryness)	1-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Insertion	Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)	Dispense
Ease of Insertion	Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)	2-weeks
Ease of Insertion	Subjective rating of ease of inserting the lens onto the eye (scale 0-10; 0=very difficult, 10=very easy)	1-month
Ease of Removal	Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)	2-weeks
Ease of Removal	Subjective rating of ease of removing the lens from the eye (scale 0-10; 0=very difficult, 10=very easy)	1 month

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2018
• Primary Completion (Actual): October 15, 2018
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 9, 2018

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-91

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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