Soft Lens Study: Biomedics 1 Day Extra Sphere and Clariti 1 Day Sphere

CooperVision International Limited (CVIL)

Status: Active, not recruiting

Conditions: Myopia

Treatments: Device: Lens 2 (somofilcon A); Device: Lens 1 (ocufilcon D)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06817785

EX-MKTG-164

Details and patient eligibility

About

The aim of this study is to evaluate and compare the performance of two soft contact lenses.

Full description

The aim of this study is to evaluate and compare the performance of a hydrogel lens and a silicone hydrogel lens in existing myopic soft lens wearers.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Are at least 18 years of age and have full legal capacity to volunteer;
2. Have understood and signed an information consent letter;
3. Are willing and able to maintain the appointment schedule;
4. Are an adapted soft contact lens wearer;
5. Have a vertex-corrected contact lens prescription of -1.00DS to -6.00DS (inclusive) in each eye;
6. Have a refraction with a cylinder component of no more than -1.00DC in each eye;
7. Can be fitted with and achieve a distance visual acuity of +0.10 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 would contraindicate contact lens use;
4. Are using any systemic or topical medications that would contraindicate contact lens use;
5. Have known sensitivity to the diagnostic fluorescein sodium to be used in the study;
6. 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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50 participants in 2 patient groups

Lens 1 (ocufilcon D)

Experimental group

Description:

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

Treatment:

Device: Lens 1 (ocufilcon D)

Lens 2 (somofilcon A)

Experimental group

Description:

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

Treatment:

Device: Lens 2 (somofilcon A)