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

Ametropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02553681
• Other study ID #: CM-002-001
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: February 16, 2017

Study information

• Verified date: August 2020
• Source: Contamac Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 16, 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ametropia
• Refractive Errors

Intervention

Device:
• roflufocon D contact lenses
HPT treated rigid contact lenses
• RGP contact lenses made from roflufocon D

Locations

Country	Name	City	State
Germany	Siehste	Kassel

Sponsors (2)

Lead Sponsor	Collaborator
Contamac Ltd	Hartwig Research Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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