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

NCT05933772 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-149
• Study Type: interventional
• Target: 50
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Distance Visual Acuity

  At the end of one month of wear

Study Arms (2)

Lens A, Then Lens B

EXPERIMENTAL

Participants will wear Lens A for one month and then crossover to Lens B for one month.

Device: Lens A (comfilcon A toric lens); Device: Lens B (lehfilcon A toric lens)

Lens B, Then Lens A

EXPERIMENTAL

Participants will wear Lens B for one month and then crossover to Lens A for one month.

Device: Lens A (comfilcon A toric lens); Device: Lens B (lehfilcon A toric lens)

Interventions

Lens A (comfilcon A toric lens) DEVICE

One month wear

Lens A, Then Lens B; Lens B, Then Lens A

Lens B (lehfilcon A toric lens) DEVICE

One month wear

Lens A, Then Lens B; Lens B, Then Lens A

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Self-reports having a full eye examination in the previous two years;
• Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Habitually wears of toric soft contact lenses binocularly.
• No more than 1/3 of the participants should be wearing daily disposable soft toric lenses;
• 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)

You may not qualify if:

• Is participating in any concurrent clinical or research study;
• Has any known active ocular disease and/or infection that contraindicates contact lens wear;
• 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 contact lens wear or a study outcome variable;
• Has known sensitivity to the diagnostic sodium fluorescein used in the study;
• Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
• Has undergone refractive error surgery or intraocular surgery.

Sponsors & Collaborators

• CooperVision International Limited (CVIL): lead
• Centre for Ocular Research & Education, Canada: collaborator

Study Sites (5)

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

ProCare Vision Center

Granville, Ohio, 43023, United States

Location

Eyes on Sheppard Clinic

Toronto, Ontario, M2N 3A4, Canada

Location

Spadina Optometry

Toronto, Ontario, M5V 3E7, Canada

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose A. Vega,OD,MSc,FAAO
• Organization: CooperVision

jvega2@coopervision.com

925-621-3761

Study Officials

• Andrew Sacco

  Sacco Eye Group

  PRINCIPAL INVESTIGATOR

• David Wilkinson

  Spadina Optometry

  PRINCIPAL INVESTIGATOR

• Fiona Soong

  Eyes on Sheppard Clinic

  PRINCIPAL INVESTIGATOR

• Katherine Bickle

  ProCare Vision Center

  PRINCIPAL INVESTIGATOR

• Shane R. Kannarr

  Kannarr Eye Care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 6, 2023
• Study Start: August 18, 2023
• Primary Completion: December 28, 2023
• Study Completion: December 28, 2023
• Last Updated: March 11, 2025
• Results First Posted: March 10, 2025

Record last verified: 2023-05

Locations

CA (2); US (3)