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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
Sponsored by
Contamac Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
July 22, 2015
Last Updated
August 10, 2020
Sponsor
Contamac Ltd
Collaborators
Hartwig Research Center
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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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

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
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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