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A Clinical Performance of Two Soft Toric Contact Lenses

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05633082
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
9
Actual Duration (Days)
135.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study objective was to gather short-term clinical performance data for two soft toric contact lenses.

Condition or Disease Intervention/Treatment Phase
  • Device: Lens 1
  • Device: Lens 2
 N/A

Detailed Description

This subject-masked, non-randomized, controlled non-dispensing study was to compare the performance of two soft toric lenses, in a single study visit.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Clinical Performance of Two Soft Toric Contact Lenses
Actual Study Start Date :
Sep 21, 2022
Actual Primary Completion Date :
Sep 30, 2022
Actual Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Lens 1

Subjects will wear Lens 1 for the first period of 15 minutes and Lens 2 for the second period of 15 minutes.

Device: Lens 1
Lens 1 - first period of 15 minutes
Other Names:
  • Toric Contact Lens

    		•
    Experimental: Lens 2

    Subjects will wear Lens 2 for the second period of 15 minutes.

    Device: Lens 2
    Lens 2 - second period of 15 minutes
    Other Names:
  • Toric Contact Lens

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Subjective Overall Score [15 minutes]

      Subjective Overall Score will be assessed using 0-100 visual analogue scales where 0=Extremely poor, 100=Excellent

    Secondary Outcome Measures

    1. Comfort [15 minutes]

      Comfort will be assessed using 0-100 visual analogue scales where 0=Causes pain,100=Excellent

    2. Vision [15 minutes]

      Vision will be assessed using 0-100 visual analogue scales where 0=Unacceptable,100=Excellent

    Eligibility Criteria

    Criteria

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

    • They are of legal age (18) and capacity to volunteer.

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

    • They are willing and able to follow the protocol.

    • They currently wear soft contact lenses, or have done so within the past two years.

    • They have ocular astigmatism in both eyes of between 0.75DC and 3.00DC.

    • They are expected to be able to be fitted with the study lenses within the power range available.

    Exclusion Criteria:

    • They have an ocular disorder which would normally contra-indicate contact lens wear.

    • They have a systemic disorder which would normally contra-indicate contact lens wear.

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

    • They are aphakic.

    • They have had corneal refractive surgery.

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

    • They are pregnant or lactating.

    • They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.

    • They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Eurolens Research Manchester United Kingdom M13 9PL

    Sponsors and Collaborators

    • Coopervision, Inc.

    Investigators

    • Principal Investigator: Philip Morgan, PhD, MCOptom, Eurolens Research

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Coopervision, Inc.
    ClinicalTrials.gov Identifier:
    NCT05633082
    Other Study ID Numbers:
    • EX-MKTG-143
    First Posted:
    Dec 1, 2022
    Last Update Posted:
    Dec 1, 2022
    Last Verified:
    Nov 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:
    Astigmatism

    Study Results

    No Results Posted as of Dec 1, 2022