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

Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Roflufocon D

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.

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Device: roflufocon D contact lenses; Device: RGP contact lenses made from roflufocon D

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Kassel, Germany
    • Siehste

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPT treated; Hydra-PEG Treatment (HPT) treated RGP contact lenses made from roflufocon D	Device: roflufocon D contact lenses; HPT treated rigid contact lenses
Active Comparator: untreated; untreated RGP contact lenses made from roflufocon D	Device: RGP contact lenses made from roflufocon D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
questionnaire addressing subjective comfort and wear time	Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.	subjects will be followed-up for one month
conjunctival redness - ocular biomicroscopy	Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.	subjects will be followed-up for one month
corneal staining - ocular biomicroscopy	Graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.	subjects will be followed-up for one month

Collaborators and Investigators

• Sponsor: Contamac Ltd
• Collaborators: Hartwig Research Center
• Investigators: Principal Investigator: Andreas Hartwig, PhD, FAAO, Hartwig Research Center

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 16, 2017

Study Registration Dates

• First Submitted: July 22, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CM-002-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No