Clinical Evaluation of Proclear Toric and Biofinity Toric

CooperVision, Inc.

Status: Completed

Conditions: Astigmatism

Treatments: Device: Lens B (comfilcon A); Device: Lens A (omafilcon B)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06431061

EX-MKTG-158

Details and patient eligibility

About

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

Full 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.

Enrollment: 37 patients

Sex: All

Ages: 17+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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37 participants in 2 patient groups

Lens A (omafilcon B)

Experimental group

Description:

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

Treatment:

Device: Lens A (omafilcon B)

Lens B (comfilcon A)

Experimental group

Description:

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

Treatment:

Device: Lens B (comfilcon A)