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

Completed

Conditions: Myopia

Interventions: Device: omafilcon A control lens
Device: omafilcon A test lens 1
Device: omafilcon A test lens 2

Registration Number: NCT04709237

Lead Sponsor: Coopervision, Inc.

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

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 21

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2	omafilcon A control lens	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.
Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2	omafilcon A test lens 2	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.
Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1	omafilcon A control lens	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.
Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2	omafilcon A test lens 1	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.
Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1	omafilcon A test lens 1	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.
Omafilcon A Test Lens 2 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 1	omafilcon A test lens 2	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.
Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2	omafilcon A test lens 1	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.
Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2	omafilcon A control lens	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.
Omafilcon A Test Lens 1 first, then Omafilcon A Control Lens , then Omafilcon A Test Lens 2	omafilcon A test lens 2	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.

Primary Outcome Measures

Name	Time	Method
Overall Vision Satisfaction	10 days	Overall vision satisfaction recorded on a visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)
Habitual Daily Wearing Time	10 days	Habitual daily wearing time in hours

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	10 days	Visual acuity measured using logMAR
Overall Visual Satisfaction During the Use of iPad With White Screen	10 days	Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)
Visual Satisfaction During the Use of iPad With Black Screen- How Happy the Vision is.	10 Days	Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)
Visual Satisfaction During the Use of Ipad With White Screen- How Clear is the Close-up Vision.	10 Days	Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Clear at All, 100 - Very Clear)
Visual Satisfaction During the Use of Ipad With Black Screen- How Clear is the Close-up the Vision is.	10 Days	Visual satisfaction during specific visual tasks on visual analog scale of 0 to100 (0 - Not Clear at All, 100 - Very Clear)