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

NCT02553681 | Completed

• 1 other identifier: CM-002-001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

HPT treated

EXPERIMENTAL

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

Device: roflufocon D contact lenses

untreated

ACTIVE COMPARATOR

untreated RGP contact lenses made from roflufocon D

Device: RGP contact lenses made from roflufocon D

Interventions

roflufocon D contact lenses DEVICE

HPT treated rigid contact lenses

HPT treated

RGP contact lenses made from roflufocon D DEVICE

untreated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Contamac Ltd: lead
• Hartwig Research Center: collaborator

Study Sites (1)

Siehste

Kassel, Germany

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Andreas Hartwig, PhD, FAAO

  Hartwig Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2015
• First Posted: September 17, 2015
• Study Start: July 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 16, 2017
• Last Updated: August 12, 2020

Record last verified: 2020-08

Locations

DE (1)