Clinical Evaluation of Proclear Toric and Biofinity Toric

NCT06431061 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-158
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the short-term clinical performance of two Toric contact lenses.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (1)

• Overall Fit Acceptance

  Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect)

  After 15 minutes of continuous wear

Study Arms (2)

Lens A (omafilcon B)

EXPERIMENTAL

All participants will wear lens A for 15 minutes (Period 1).

Device: Lens A (omafilcon B)

Lens B (comfilcon A)

EXPERIMENTAL

All participants will wear lens B for 15 minutes (Period 2).

Device: Lens B (comfilcon A)

Interventions

Lens A (omafilcon B) DEVICE

15 minutes of daily wear.

Lens A (omafilcon B)

Lens B (comfilcon A) DEVICE

15 minutes of daily wear.

Lens B (comfilcon A)

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Are at least 17 years of age and has full legal capacity to volunteer.
• Have understood and signed an information consent letter.
• Are willing and able to follow instructions and maintain the appointment schedule.
• Are an adapted soft toric contact lens wearer.
• Do not habitually wear either of the two study lens types.
• Have a vertex-corrected contact lens prescription with a spherical component of +4.00D to -9.00D in combination with astigmatism of no less than -0.75D and no more than -2.25D in each eye.
• Can achieve best corrected distance visual acuity of +0.10 logMAR (subjective refraction) or better in each eye.
• Can be fitted with and achieve a distance visual acuity of +0.18 logMAR or better in each eye with the study contact lenses.

You may not qualify if:

• Are participating in any concurrent clinical or research study.
• Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use.
• Have a systemic condition that in the opinion of the investigator may affect a study outcome variable.
• Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable.
• Have known sensitivity to the diagnostic pharmaceuticals to be used in the study.
• Have a history of not achieving comfortable CL use (5 days per week; \> 8 hours/day)
• Are an employee of the Centre for Ocular Research \& Education directly involved in the study (i.e. on the delegation log).

Sponsors & Collaborators

• CooperVision, Inc.: lead
• Centre for Ocular Research & Education, Canada: collaborator

Study Sites (1)

University of Waterloo

Waterloo, Canada

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

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

JVega2@coopervision.com

925-621-3761

Study Officials

• Lyndon Jones

  Centre for Ocular Research and Education

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 28, 2024
• Study Start: June 4, 2024
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Locations

CA (1)