Clinical trial NCT04709237: Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia Control
Official title: Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2021-01-14
Enrollment: 21
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Overall Vision Satisfaction
timeFrame: 10 days
measure: Habitual Daily Wearing Time
timeFrame: 10 days
Secondary outcomes:
measure: Visual Acuity
timeFrame: 10 days
measure: Overall Visual Satisfaction During the Use of iPad With White Screen
timeFrame: 10 days
measure: Visual Satisfaction During the Use of Ipad With White Screen- How Clear is the Close-up Vision.
timeFrame: 10 Days
measure: Visual Satisfaction During the Use of iPad With Black Screen- How Happy the Vision is.
timeFrame: 10 Days
measure: Visual Satisfaction During the Use of Ipad With Black Screen- How Clear is the Close-up the Vision is.
timeFrame: 10 Days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Ocular Technology Group - International
Study officials:
References: