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

Coopervision, Inc.1 site in 1 country21 target enrollmentDecember 14, 2019

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Coopervision, Inc.
Enrollment: 21
Locations: 1
Primary Endpoint: Overall Vision Satisfaction
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 14, 2019

End Date

March 31, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Coopervision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Overall Vision Satisfaction

Time Frame: 10 days

Overall vision satisfaction recorded on a visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)

Habitual Daily Wearing Time

Time Frame: 10 days

Habitual daily wearing time in hours

Secondary Outcomes

Visual Acuity(10 days)
Overall Visual Satisfaction During the Use of iPad With White Screen(10 days)
Visual Satisfaction During the Use of iPad With Black Screen- How Happy the Vision is.(10 Days)
Visual Satisfaction During the Use of Ipad With White Screen- How Clear is the Close-up Vision.(10 Days)
Visual Satisfaction During the Use of Ipad With Black Screen- How Clear is the Close-up the Vision is.(10 Days)