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

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ClinicalTrials.gov Identifier: NCT02553681
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
Hartwig Research Center
Information provided by (Responsible Party):
Contamac Ltd

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.

Condition or disease Intervention/treatment Phase
Ametropia Device: roflufocon D contact lenses Device: RGP contact lenses made from roflufocon D Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Roflufocon D
Study Start Date : July 2015
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: HPT treated
Hydra-PEG Treatment (HPT) treated RGP contact lenses made from roflufocon D
Device: roflufocon D contact lenses
HPT treated rigid contact lenses

Active Comparator: untreated
untreated RGP contact lenses made from roflufocon D
Device: RGP contact lenses made from roflufocon D



Primary Outcome Measures :
  1. questionnaire addressing subjective comfort and wear time [ Time Frame: subjects will be followed-up for one month ]
  2. ocular biomicroscopy [ Time Frame: subjects will be followed-up for one month ]
    conjunctival redness

  3. ocular biomicroscopy [ Time Frame: subjects will be followed-up for one month ]
    corneal staining



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553681


Locations
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Germany
Siehste
Kassel, Germany
Sponsors and Collaborators
Contamac Ltd
Hartwig Research Center

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Responsible Party: Contamac Ltd
ClinicalTrials.gov Identifier: NCT02553681     History of Changes
Other Study ID Numbers: CM-002-001
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases