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

Primary Purpose

Ametropia

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

roflufocon D contact lenses

RGP contact lenses made from roflufocon D

About this trial

This is an interventional treatment trial for Ametropia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Siehste

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HPT treated

untreated

Arm Description

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

untreated RGP contact lenses made from roflufocon D

Outcomes

Primary Outcome Measures

questionnaire addressing subjective comfort and wear time

Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.

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.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT02553681

First Posted

July 22, 2015

Last Updated

August 10, 2020

Sponsor

Contamac Ltd

Collaborators

Hartwig Research Center

1. Study Identification

Unique Protocol Identification Number

NCT02553681

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2020

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Contamac Ltd

Collaborators

Hartwig Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ametropia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HPT treated

Arm Type

Experimental

Arm Description

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

Arm Title

untreated

Arm Type

Active Comparator

Arm Description

untreated RGP contact lenses made from roflufocon D

Intervention Type

Device

Intervention Name(s)

roflufocon D contact lenses

Intervention Description

HPT treated rigid contact lenses

Intervention Type

Device

Intervention Name(s)

RGP contact lenses made from roflufocon D

Primary Outcome Measure Information:

Title

questionnaire addressing subjective comfort and wear time

Description

Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.

Time Frame

subjects will be followed-up for one month

Title

conjunctival redness - ocular biomicroscopy

Description

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.

Time Frame

subjects will be followed-up for one month

Title

corneal staining - ocular biomicroscopy

Description

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.

Time Frame

subjects will be followed-up for one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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:• 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Hartwig, PhD, FAAO

Organizational Affiliation

Hartwig Research Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siehste

City

Kassel

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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