Clinical Evaluation of Proclear Toric and Biofinity Toric

NCT06431061 — Not applicable, Completed, 37 participants, CooperVision, Inc.

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Registry	NCT06431061
Status	Completed
Phase	Not applicable
Study type	Interventional; non randomized, crossover, masking: single, treatment
Enrollment	37 (Actual)
Sponsor	CooperVision, Inc. (Industry); collaborators: Centre for Ocular Research & Education, Canada
Conditions	Astigmatism
Interventions	Lens A (omafilcon B), Lens B (comfilcon A) (Device)
Dates	start 2024-06-04, primary completion 2024-11-13, completion 2024-11-13, first posted 2024-05-28, last updated 2025-09-15
Locations	1 site in Canada

-Summary

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

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+Detailed description

The aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study.

+Arms and interventions

Arm	Type	Interventions	Description
Lens A (omafilcon B)	Experimental	Device: Lens A (omafilcon B)	All participants will wear lens A for 15 minutes (Period 1).
Lens B (comfilcon A)	Experimental	Device: Lens B (comfilcon A)	All participants will wear lens B for 15 minutes (Period 2).

Lens A (omafilcon B) (Device): 15 minutes of daily wear.
Lens B (comfilcon A) (Device): 15 minutes of daily wear.

+Outcome measures

Primary outcomes

Overall Fit Acceptance [After 15 minutes of continuous wear]: Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect)

+Eligibility

Sex: All, ages: 17 Years to any

Inclusion Criteria:

1. Are at least 17 years of age and has full legal capacity to volunteer.
2. Have understood and signed an information consent letter.
3. Are willing and able to follow instructions and maintain the appointment schedule.
4. Are an adapted soft toric contact lens wearer.
5. Do not habitually wear either of the two study lens types.
6. 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.
7. Can achieve best corrected distance visual acuity of +0.10 logMAR (subjective refraction) or better in each eye.
8. Can be fitted with and achieve a distance visual acuity of +0.18 logMAR or better in each eye with the study contact lenses.

Exclusion Criteria:

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

+Posted results

Participant flow

Milestone	Lens A (Omafilcon B)	Lens B (Comfilcon A)
Started	37	0
Completed	37	0
Not completed	0	0

Outcome results

Overall Fit Acceptance (Primary), Mean, Units on Scale: Lens A (Omafilcon B) 3.5 +/- 0.7; Lens B (Comfilcon A) 3.8 +/- 0.4

Adverse events

Time frame: Through study completion, approximately 23 weeks

Arm	Deaths	Serious adverse events	Other adverse events
Lens A (Omafilcon B)	0/37 (0.0%)	0/37 (0.0%)	0/37 (0.0%)
Lens B (Comfilcon A)	0/37 (0.0%)	0/37 (0.0%)	0/37 (0.0%)

+Locations (1)

Facility	City	Country	Status
University of Waterloo	Waterloo	Canada

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2024-05-01)

+Investigators

Lyndon Jones, Principal investigator, Centre for Ocular Research and Education