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

NCT ID: NCT04525170

Last Updated: 2020-08-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-12-31

Brief Summary

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.

Conditions

Ametropia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HPT treated

daily wear Hexafocon A rigid contact lens treated with Hydra PEG surface coating

Group Type: EXPERIMENTAL

HPT treatment

Intervention Type: DEVICE

untreated

daily wear Hexafocon A rigid contact lens

Group Type: EXPERIMENTAL

untreated

Intervention Type: DEVICE

Interventions

HPT treatment

Intervention Type: DEVICE

untreated

Intervention Type: DEVICE

Other Intervention Names

Hydra-PEG (Polyethylene Glycol) Treatment

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Contamac Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Hartwig, PhD

Role: PRINCIPAL_INVESTIGATOR

Hartwig Research Center

Locations

Hartwig Research Center

Heikendorf, S-H, Germany

Siehste

Kassel, , Germany

Countries

Germany

Other Identifiers

CM-002-002

Identifier Type: -

Identifier Source: org_study_id