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Clinical Evaluation of Two Silicone Hydrogel Contact Lenses

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT05313412
Collaborator
(none)
38
Enrollment
1
Location
2
Arms
4.1
Anticipated Duration (Months)
9.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to compare the short-term clinical performance and subjective acceptance of two silicone hydrogel soft contact lenses.

Condition or Disease Intervention/Treatment Phase
  • Device: Test silicone hydrogel contact lens
  • Device: Control silicone hydrogel contact lens
 N/A

Detailed Description

This is a double-masked, randomized, bilateral crossover study to compare the short-term clinical performance of two silicone hydrogel soft contact lenses.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Two Silicone Hydrogel Contact Lenses
Actual Study Start Date :
Jan 24, 2022
Actual Primary Completion Date :
Apr 20, 2022
Anticipated Study Completion Date :
May 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Test silicone hydrogel contact lenses (Lens A)

Test Lens A

Device: Test silicone hydrogel contact lens
Subjects will be randomized to wear test lens A for 6 hours.
Other Names:
  • Lens A

    • Device: Control silicone hydrogel contact lens
    Subjects will be randomized to wear control lens B for 6 hours.
    Other Names:
  • Lens B

    		•
    Active Comparator: Control silicone hydrogel contact lenses (Lens B)

    Control Lens B

    Device: Test silicone hydrogel contact lens
    Subjects will be randomized to wear test lens A for 6 hours.
    Other Names:
  • Lens A

    • Device: Control silicone hydrogel contact lens
    Subjects will be randomized to wear control lens B for 6 hours.
    Other Names:
  • Lens B

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Ease of Lens Insertion [Up to 6 hours]

      Ease of Lens Insertion will be measured on a scale of 0-100 (0- Unmanageable, Lenses impossible to insert, 100- Excellent. No problems with lens insertion.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. They are aged between 18 and 40 years.

    2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.

    3. They are willing and able to follow the protocol.

    4. They have successfully worn contact lenses within six months of starting the study.

    5. They can be satisfactorily fitted with the study contact lenses.

    6. They have a contact lens spherical prescription between -0.25 to - 6.00D (inclusive) based on the ocular refraction.

    7. They have a spectacle cylindrical correction of -0.75D or less in each eye based on the ocular refraction.

    8. They own and habitually wear single vision spectacles.

    9. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye, with the study lenses.

    10. They agree not to participate in other clinical research while enrolled on this study.

    Exclusion Criteria:

    1. They have an ocular disorder which would normally contraindicate contact lens wear.

    2. They have a systemic disorder which would normally contraindicate contact lens wear.

    3. They are using any topical medication such as eye drops or ointment.

    4. They are aphakic.

    5. They have had corneal refractive surgery.

    6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

    7. They are pregnant or breastfeeding.

    8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (eg HIV) or a history of anaphylaxis or severe allergic reaction.

    9. They have grade 3 or greater of any of the following ocular surface signs: corneal oedema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality, which would normally contraindicate contact lens wear.

    10. They have taken part in any other clinical trial or research, within two weeks prior to starting this study, which may impact on this particular work.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eurolens Research Manchester United Kingdom

    Sponsors and Collaborators

    • Coopervision, Inc.

    Investigators

    • Principal Investigator: Philip Morgan, Eurolens Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT05313412
    Other Study ID Numbers:
    • C21-706 (EX-MKTG-127)
    First Posted:
    Apr 6, 2022
    Last Update Posted:
    May 6, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of May 6, 2022