Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia Control

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: omafilcon A control lens; Device: omafilcon A test lens 1; Device: omafilcon A test lens 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT04709237

CV-20-51

Details and patient eligibility

About

The main objective of the study was to evaluate the clinical acceptance of soft contact lenses for Myopia control.

Full description

Participants were randomized to wear each study contact lenses for 10 days with investigator and participant masking. The participants who are not contact lens wearer at enrollment wore single vision contact lenses for two weeks during the pre-investigation phase to get adapted to contact lens wear.

Enrollment: 21 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 10 to 16 years;
• Spectacle refraction: -0.75 to -6.00D spherical equivalent, maximum anisometropia 1.25D, cylinder up to -1.00DC
• Best corrected visual acuity of at least 20/25 in each eye.
• Parents/guardians and participant have read and understood the Participant Information Sheet;
• Parents/guardians and participant have read, signed and dated the Informed Consent;
• Have normal eyes with the exception of the need for visual correction;
• Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.

Exclusion criteria

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Newly prescribed use of some systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
• Monocular participants (only one eye with functional vision) or participants fit with only one lens;
• Subjects with slit lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit;
• History of herpetic keratitis, ocular surgery or irregular cornea;
• Enrolment of the family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 3 patient groups

Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2

Experimental group

Description:

Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.

Treatment:

Device: omafilcon A test lens 2

Device: omafilcon A test lens 1

Device: omafilcon A control lens

Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1

Experimental group

Description:

Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.

Treatment:

Device: omafilcon A test lens 2

Device: omafilcon A test lens 1

Device: omafilcon A control lens

Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2

Experimental group

Description:

Participants wore three different types of study contact lenses (1 control and 2 test contact lenses), in a randomized order of testing for the three study contact lens types.

Treatment:

Device: omafilcon A test lens 2

Device: omafilcon A test lens 1

Device: omafilcon A control lens