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

Sponsor
Contamac Ltd (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04525170
Collaborator
(none)
0
Enrollment
2
Locations
2
Arms
3
Actual Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: HPT treatment
  • Device: untreated
 N/A

Study Design

Study Type:
Interventional
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 :
Sep 1, 2015
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: HPT treated

daily wear Hexafocon A rigid contact lens treated with Hydra PEG surface coating

Device: HPT treatment
Other Names:
  • Hydra-PEG (Polyethylene Glycol) Treatment

    		•
    Experimental: untreated

    daily wear Hexafocon A rigid contact lens

    Device: untreated

    Outcome Measures

    Primary Outcome Measures

    1. questionnaire addressing subjective comfort and wear time [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 [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 [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.

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hartwig Research Center Heikendorf S-H Germany 24226
    2 Siehste Kassel Germany

    Sponsors and Collaborators

    • Contamac Ltd

    Investigators

    • Principal Investigator: Andreas Hartwig, PhD, Hartwig Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Contamac Ltd
    ClinicalTrials.gov Identifier:
    NCT04525170
    Other Study ID Numbers:
    • CM-002-002
    First Posted:
    Aug 25, 2020
    Last Update Posted:
    Aug 25, 2020
    Last Verified:
    Aug 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    No Results Posted as of Aug 25, 2020