Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Roflufocon D

NCT ID: NCT02553681

Last Updated: 2020-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2017-02-16

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

Hydra-PEG Treatment (HPT) treated RGP contact lenses made from roflufocon D

Group Type: EXPERIMENTAL

roflufocon D contact lenses

Intervention Type: DEVICE

HPT treated rigid contact lenses

untreated

untreated RGP contact lenses made from roflufocon D

Group Type: ACTIVE_COMPARATOR

RGP contact lenses made from roflufocon D

Intervention Type: DEVICE

Interventions

roflufocon D contact lenses

HPT treated rigid contact lenses

Intervention Type: DEVICE

RGP contact lenses made from roflufocon D

Intervention Type: DEVICE

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 Contamac's Optimum Extra (roflufocon D) 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

• 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

Hartwig Research Center

INDUSTRY

Sponsor Role: collaborator

Contamac Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Hartwig, PhD, FAAO

Role: PRINCIPAL_INVESTIGATOR

Hartwig Research Center

Locations

Siehste

Kassel, , Germany

Countries

Germany

Other Identifiers

CM-002-001

Identifier Type: -

Identifier Source: org_study_id