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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02553681
Other study ID # CM-002-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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