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Contact lens safety and performance study

Comfilcon A contact lenses medical device regulation study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN14700465
Enrollment
182
Registered
2023-08-30
Start date
2023-08-18
Completion date
Unknown
Last updated
2023-09-11

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

Conditions

Presbyopia, myopia, hyperopia, astigmatism Eye Diseases

Interventions

Sponsors

Cooper Vision International Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Contact lens wearers using comfilcon A family of contact lenses comprising Biofinity® and private label, sphere, toric, multifocal, toric multifocal 2. Age 8-75 years 3. Current wearer of one of the above contact lens types for at least 12 months managed by referring practice 4. At least occasional overnight wear in the last 12 months 5. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment scheduled at OTG-i

Exclusion criteria

Exclusion criteria: Current participation of the subject in a contact lens or contact lens care product clinical trial

Design outcomes

Primary

MeasureTime frame
logMAR photopic (200 cd/m2) high contrast (>90%) visual acuity at distance (400 cm) and near (40 cm) measured to the nearest letter, measured at a single timepoint during the visit

Secondary

MeasureTime frame
1. Comfort recorded on a six-point scale, measured at a single timepoint during the visit 2. Vision recorded on a six-point scale, measured at a single timepoint during the visit 3. Handling recorded on a six-point scale, measured at a single timepoint during the visit

Countries

England, United Kingdom

Contacts

Public ContactDeborah Moore
dmoore@otg.co.uk+44 (0)207 222 4224

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026