Comprehensive Assessment of Multiple Products (CAMP)

CooperVision International Limited (CVIL)

Status: Enrolling

Conditions: Myopia; Hyperopia

Treatments: Device: comfilcon A lens; Device: senofilcon A bi-weekly lens; Device: stenfilcon A lens; Device: kalilfilcon A lens; Device: delefilcon A lens; Device: verofilcon A lens; Device: fanfilcon A lens; Device: samfilcon A lens; Device: senofilcon A daily disposable lens; Device: senofilcon A with blue light technology lens; Device: lehfilcon A lens; Device: somofilcon A lens; Device: serafilcon A lens

Study type: Interventional

Funder types: Industry

Identifiers

NCT07276347

EX-MKTG-167

Details and patient eligibility

About

The aim of this study is to assess contact lens performance and acceptance.

Full description

The objective of this study is to assess the initial performance and acceptance of a range of contact lenses in habitual soft contact lens wearers.

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18 to 45 years (inclusive)
2. Habitual soft spherical contact lens wearer (current prescription)
3. Refractive error of -6.00 to -0.50DS or +0.50 to +6.00DS and less than or equal to 0.75DC as vertexed to the corneal plane
4. Anisometropia no greater than 1.50D, based on vertexed manifest refraction spherical equivalent
5. Can achieve visual acuity of at least 20/25 in each eye with spherical equivalent manifest refraction

Exclusion criteria

1. Active anterior segment infection, inflammation or abnormality that would contraindicate contact lens wear
2. Use of systemic or ocular medication that would contraindicate contact lens wear
3. Used gas permeable/hard contact lenses (including orthokeratology) in the previous 3 months
4. Participation in a contact lens or lens care product trial in the previous 30 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

250 participants in 13 patient groups

somofilcon A lens

Experimental group

Description:

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.

Treatment:

Device: somofilcon A lens

stenfilcon A lens

Experimental group

Description:

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.

Treatment:

Device: stenfilcon A lens

fanfilcon A lens

Experimental group

Description:

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.

Treatment:

Device: fanfilcon A lens

comfilcon A lens

Experimental group

Description:

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.

Treatment:

Device: comfilcon A lens

verofilcon A lens

Experimental group

Description:

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.

Treatment:

Device: verofilcon A lens

serafilcon A lens

Experimental group

Description:

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.

Treatment:

Device: serafilcon A lens

lehfilcon A lens

Experimental group

Description:

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.

Treatment:

Device: lehfilcon A lens

delefilcon A lens

Experimental group

Description:

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.

Treatment:

Device: delefilcon A lens

senofilcon A lens daily disposable

Experimental group

Description:

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.

Treatment:

Device: senofilcon A daily disposable lens

senofilcon A lens with blue light technology

Experimental group

Description:

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.

Treatment:

Device: senofilcon A with blue light technology lens

senofilcon A lens bi-weekly replacement

Experimental group

Description:

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.

Treatment:

Device: senofilcon A bi-weekly lens

samfilcon A lens

Experimental group

Description:

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.

Treatment:

Device: samfilcon A lens

kalifilcon A lens

Experimental group

Description:

Participants will wear thirteen different types of study contact lenses, in a randomized order of testing for the thirteen study contact lens types.

Treatment:

Device: kalilfilcon A lens