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One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses

Sponsor
Contamac Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT02312323
Collaborator
Hartwig Research Center (Industry)
35
Enrollment
2
Locations
2
Arms
6.4
Actual Duration (Months)
17.5
Patients Per Site
2.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Comparison of different contact lens materials.

Condition or Disease Intervention/Treatment Phase
  • Device: Definitive 65 HPT contact lenses
  • Device: Definitive 65 contact lenses
 N/A

Detailed Description

This is a 1-month, open-label, bilateral, parallel-group, randomised, daily wear study. Two-thirds of the subjects will wear the Test lenses in both eyes, and one-third will wear the Control lenses in both eyes.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
One-month Clinical Evaluation of Silicone Hydrogel Definitive 65 HPT Contact Lenses
Actual Study Start Date :
Nov 8, 2014
Actual Primary Completion Date :
May 23, 2015
Actual Study Completion Date :
May 23, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Definitive 65 HPT

The Test product were the Definitive 65 (Filcon V4) lenses with Hydra PEG surface coating. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG.

Device: Definitive 65 HPT contact lenses
Other Names:
  • Filcon V4 (HPT)

    		•
    Active Comparator: Definitive 65

    The Control product was the commercially available Definitive 65 (Efrofilcon A) lens. This material is produced by Contamac Ltd. and the contact lenses were manufactured by Appenzeller Kontaktlinsen AG.

    Device: Definitive 65 contact lenses
    Other Names:
  • Filcon V4

    		•

    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]

      Assessed using slit lamp with white light, low-medium magnification. 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. conjunctival redness - ocular biomicroscopy [subjects will be followed-up for one month]

      Assessed using slit lamp with white light, low-medium magnification. 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.

    4. corneal staining - ocular biomicroscopy [subjects will be followed-up for one month]

      Assessed using slit lamp with white light, low-medium magnification. 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 informed consent form

    • ages 18 years or older

    • 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)

    • Astigmatic power ≤0.75 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

    • 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 Siehste Kassel Germany
    2 Kresinky Würzburg Germany

    Sponsors and Collaborators

    • Contamac Ltd
    • Hartwig Research Center

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Contamac Ltd
    ClinicalTrials.gov Identifier:
    NCT02312323
    Other Study ID Numbers:
    • CM-001-002
    First Posted:
    Dec 9, 2014
    Last Update Posted:
    Aug 12, 2020
    Last Verified:
    Aug 1, 2020
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    No Results Posted as of Aug 12, 2020