Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Hexafocon A

Contamac

Status

Withdrawn

Conditions

Ametropia

Treatments

Device: HPT treatment

Device: untreated

Study type

Interventional

Funder types

Industry

Identifiers

NCT04525170

CM-002-002

Details and patient eligibility

About

This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Willing and able to sign the informed consent form
Aged ≥18 years old
Experienced wearer of rigid gas permeable contact lenses
Subject's habitual contact lenses must be made of Boston XO (hexafocon A) material
Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
Spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
Corneal astigmatism ≤2.00 D

Exclusion criteria

Eye injury or surgery within 3 months immediately prior to enrolment for this trial
Pre-existing ocular irritation that would preclude contact lens fitting
Currently enrolled in an ophthalmic clinical trial
Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator
Any use of medications for which contact lens wear could be contradicted, as determined by the investigator
Current extended-wear users (sleep-in overnight)
Current monovision lens wearers
Current wearers of multifocal contact lenses
Current wearers of toric contact lenses (front surface design)
Current wearers of astigmatic contact lenses (posterior surface design)
Has a reported "Strong" comfort or vision preference between each eye with their habitual RGP lenses
Unacceptable fit of habitual lenses
Pregnant women and nursing mothers
Best-corrected visual acuity worse than 6/9 (LogMAR: +0.20; Snellen decimal: 0.63)