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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04709237

Enrollment

Registered

2021-01-14

Start date

2019-12-14

Completion date

2021-03-31

Last updated

2024-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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.

Interventions

DEVICEomafilcon A control lens

Participants were randomized to wear omafilcon A control soft contact lens for 10 days.

DEVICEomafilcon A test lens 1

Participants were randomized to wear omafilcon A test soft contact lens 1 for 10 days.

DEVICEomafilcon A test lens 2

Participants were randomized to wear omafilcon A test soft contact lens 2 for 10 days.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

10 Years to 16 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 Acuity	10 days	Visual acuity measured using logMAR
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)
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)
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)

Countries

United Kingdom

Participant flow

Participants by arm

Arm	Count
Overall Study Nineteen total participants were analyzed out of the 20 participants who completed the study.	19
Total	19

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	1	0	0

Baseline characteristics

Characteristic	Overall Study	—
Age, Continuous	14.4 Years STANDARD_DEVIATION 1.9	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	11 Participants	—
Sex: Female, Male Male	8 Participants	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 19	0 / 19	0 / 19
other Total, other adverse events	2 / 19	0 / 19	0 / 19
serious Total, serious adverse events	0 / 19	0 / 19	0 / 19

Outcome results

Primary