Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

The objective of the study was to compare the clinical performance of two monthly toric silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: Lens A (comfilcon A toric lens); Device: Lens B (lehfilcon A toric lens)

Detailed Description

This study was a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. Each lens type will be worn bilaterally for approximately one month.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2N 3A4
      • Eyes on Sheppard Clinic
    • Toronto, Ontario, Canada, M5V 3E7
      • Spadina Optometry
• United States
  • Kansas
    • Pittsburg, Kansas, United States, 66762
      • Kannarr Eye Care
  • New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • Ohio
    • Granville, Ohio, United States, 43023
      • ProCare Vision Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Self-reports having a full eye examination in the previous two years;
4. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
5. Is willing and able to follow instructions and maintain the appointment schedule;

6. Habitually wears of toric soft contact lenses binocularly.

   1. No more than 1/3 of the participants should be wearing daily disposable soft toric lenses;

   2. the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows:

      • i. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage)
      • ii. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%))
      • iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (∼30%) (PLUS a target of minimum 7 (∼20%))
      • iv. ULTRA for Astigmatism: maximum of 5 (∼15%) (no target percentage)
      • v. Acuvue Vita for Astigmatism: maximum of 3 (∼10%) (no target percentage)
      • vi. Acuvue Oasys for Astigmatism: maximum of 10 (∼30%) (no target percentage)
      • vii. Other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage)
7. Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC;
8. Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively;
9. Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Has undergone refractive error surgery or intraocular surgery.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lens A, Then Lens B; Participants will wear Lens A for one month and then crossover to Lens B for one month.	Device: Lens A (comfilcon A toric lens); One month wear; Device: Lens B (lehfilcon A toric lens); One month wear
Experimental: Lens B, Then Lens A; Participants will wear Lens B for one month and then crossover to Lens A for one month.	Device: Lens A (comfilcon A toric lens); One month wear; Device: Lens B (lehfilcon A toric lens); One month wear

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Handling on Removal	Lens Handling on Removal, using a 0-100 scale (0= very difficult, 100=very easy).	At the end of one month of wear

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Visual Acuity	Distance Visual Acuity, using Snellen converted to logMAR.	At the end of one month of wear

Collaborators and Investigators

• Sponsor: CooperVision International Limited (CVIL)
• Collaborators: Centre for Ocular Research & Education, Canada
• Investigators: Principal Investigator: Fiona Soong, Eyes on Sheppard Clinic; Principal Investigator: David Wilkinson, Spadina Optometry; Principal Investigator: Andrew Sacco, Sacco Eye Group; Principal Investigator: Katherine Bickle, ProCare Vision Center; Principal Investigator: Shane R. Kannarr, Kannarr Eye Care

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2023
• Primary Completion (Actual): December 28, 2023
• Study Completion (Actual): December 28, 2023

Study Registration Dates

• First Submitted: June 28, 2023
• First Submitted That Met QC Criteria: June 28, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 7, 2025
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-149

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