N/A
N=21
Evaluation of The Clinical Acceptance of Soft Contact Lenses for Myopia Control
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT04709237 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Overall Vision Satisfaction — 87.7; 79.7; 71.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- omafilcon A control lens (Device); omafilcon A test lens 1 (Device); omafilcon A test lens 2 (Device)
- Age
- Pediatric · 10+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Vision Satisfaction |
87.7; 79.7; 71.8 | — |
| PRIMARY Habitual Daily Wearing Time |
7.9; 8.1; 7.8 | — |
| SECONDARY Visual Acuity |
0.06; 0.08; 0.10 | — |
| SECONDARY Overall Visual Satisfaction During the Use of iPad With White Screen |
90.8; 90.8; 85.1 | — |
| SECONDARY Visual Satisfaction During the Use of Ipad With White Screen- How Clear is the Close-up Vision. |
90.7; 90.0; 84.4 | — |
| SECONDARY Visual Satisfaction During the Use of iPad With Black Screen- How Happy the Vision is. |
85.4; 86.8; 80.0 | — |
| SECONDARY Visual Satisfaction During the Use of Ipad With Black Screen- How Clear is the Close-up the Vision is. |
85.3; 87.5; 79.2 | — |
Summary
The main objective of the study was to evaluate the clinical acceptance of soft contact lenses for Myopia control.
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.
Data sourced from ClinicalTrials.gov (NCT04709237). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.