Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia Control
1 other identifier
interventional
21
1 country
1
Brief Summary
The main objective of the study was to evaluate the clinical acceptance of soft contact lenses for Myopia control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 14, 2019
CompletedFirst Submitted
Initial submission to the registry
January 12, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedResults Posted
Study results publicly available
August 27, 2024
CompletedAugust 27, 2024
April 1, 2022
1.3 years
January 12, 2021
April 24, 2024
August 3, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Overall Vision Satisfaction
Overall vision satisfaction recorded on a visual analog scale of 0 to100 (0 - Not Happy, 100 - Very Happy)
10 days
Habitual Daily Wearing Time
Habitual daily wearing time in hours
10 days
Secondary Outcomes (5)
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 White Screen- How Clear is the Close-up Vision.
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 Black Screen- How Clear is the Close-up the Vision is.
10 Days
Study Arms (3)
Omafilcon A Control Lens first, then Omafilcon A Test Lens 1, then Omafilcon A Test Lens 2
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Participants were randomized to wear omafilcon A control soft contact lens for 10 days.
Participants were randomized to wear omafilcon A test soft contact lens 1 for 10 days.
Participants were randomized to wear omafilcon A test soft contact lens 2 for 10 days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ocular Technology Group - International
London, SW1E 6AU, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Paul Chamberlain
- Organization
- Coopervision
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2021
First Posted
January 14, 2021
Study Start
December 14, 2019
Primary Completion
March 31, 2021
Study Completion
March 31, 2021
Last Updated
August 27, 2024
Results First Posted
August 27, 2024
Record last verified: 2022-04