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Clinical investigation of soft contact lenses in children

Clinical performance of two myopia control contact lenses in children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17872996
Enrollment
35
Registered
2025-10-13
Start date
2025-09-25
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Myopia Eye Diseases

Interventions

The study will be a randomized, double-masked, non-dispensing, prospective study involving a single visit with approximately 2.5 hours of wear, to assess the short-term performance of senofilcon A (co

Sponsors

CooperVision International Limited
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. Age 8 to 15 years (inclusive) 2. Current wearer of spherical soft contact lenses 3. The parent or guardian understands the study and rights of the participant and is willing to sign a statement of informed consent. 4. The participant understands the study at a level appropriate for their age and is willing to sign a statement of assent.

Exclusion criteria

Exclusion criteria: 1. Previous use of myopia control contact lenses. 2. Active anterior segment infection, inflammation, or abnormality that would contraindicate contact lens wear. 3. Use of systemic or ocular medication that would contraindicate contact lens wear 4. Used gas permeable/hard contact lenses (including orthokeratology) in the previous 3 months. 5. Participation in a contact lens or lens care product trial in the previous 30 days.

Design outcomes

Primary

MeasureTime frame
High contrast, high luminance binocular distance visual acuity measured using the Precision-Vision Chart 2425-LED-200, at the one-day single visit. The visit is expected to take approximately 2.5 hours.

Secondary

MeasureTime frame
There are no secondary outcome measures

Countries

England, United Kingdom

Contacts

Public ContactJose;Carole Vega;Maldonado-Codina

;

jvega2@coopervision.com;carole.m-codina@manchester.ac.uk+1-925-640-2964;+44 (0)161 306 8761

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 3, 2026