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Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Hexafocon A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04525170
Recruitment Status : Withdrawn (It was decided by the sponsor to not proceed.)
First Posted : August 25, 2020
Last Update Posted : August 25, 2020
Sponsor:
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: HPT treatment Device: untreated Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Hexafocon A
Actual Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: HPT treated
daily wear Hexafocon A rigid contact lens treated with Hydra PEG surface coating
Device: HPT treatment
Other Name: Hydra-PEG (Polyethylene Glycol) Treatment

Experimental: untreated
daily wear Hexafocon A rigid contact lens
Device: untreated



Primary Outcome Measures :
  1. questionnaire addressing subjective comfort and wear time [ Time Frame: subjects will be followed-up for one month ]
    Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.

  2. limbal redness - ocular biomicroscopy [ Time Frame: subjects will be followed-up for one month ]
    Findings were 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.

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



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 Boston XO (hexafocon A) 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): NCT04525170


Locations
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Germany
Hartwig Research Center
Heikendorf, S-H, Germany, 24226
Siehste
Kassel, Germany
Sponsors and Collaborators
Contamac Ltd
Investigators
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Principal Investigator: Andreas Hartwig, PhD Hartwig Research Center
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Responsible Party: Contamac Ltd
ClinicalTrials.gov Identifier: NCT04525170    
Other Study ID Numbers: CM-002-002
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases