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Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens

Sponsor
Alcon Research (Industry)
Overall Status
Completed
CT.gov ID
NCT04464044
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
17
Actual Duration (Days)
71.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to obtain on-eye clinical performance data to evaluate the stability of axis orientation of DDT2 toric contact lenses in the intended population.

Condition or Disease Intervention/Treatment Phase
  • Device: verofilcon A toric contact lenses
 N/A

Detailed Description

This is a single-visit, non-dispense study where subjects will be exposed to the test lenses for approximately 1 hour.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Clinical Performance of a Daily Disposable Toric Silicone Hydrogel Contact Lens
Actual Study Start Date :
Jul 20, 2020
Actual Primary Completion Date :
Aug 6, 2020
Actual Study Completion Date :
Aug 6, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: DDT2 Toric

Verofilcon A toric contact lenses worn in both eyes

Device: verofilcon A toric contact lenses
Daily disposable toric soft contact lenses
Other Names:
  • DDT2 Toric

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percent of lenses with axis orientation within ±30° from the intended axis, 10 minutes after lens insertion [Day 1, 10 minutes after lens insertion]

      Axis orientation (orientation of the scribe mark) will be assessed by slit lamp examination and recorded as deviations from intended axis.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Able to understand and sign an informed consent form;

    • Successful wear of spherical or toric soft contact lenses in both eyes, as specified in the protocol;

    • Willing to NOT use rewetting/lubricating drops at any time during the study;

    • Other protocol-specified inclusion criteria may apply.

    Exclusion Criteria:

    • Any eye condition that would contraindicate contact lens wear, as determined by the Investigator;

    • History of eye surgery within the previous 12 months, as specified in the protocol;

    • Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear;

    • Other protocol-specified exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Contact Alcon Call Center for Trial Locations Fort Worth Texas United States 76134

    Sponsors and Collaborators

    • Alcon Research

    Investigators

    • Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT04464044
    Other Study ID Numbers:
    • CLA306-C003
    First Posted:
    Jul 9, 2020
    Last Update Posted:
    Aug 19, 2020
    Last Verified:
    Aug 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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.:
    No
    Keywords provided by Alcon Research
    Toric contact lens
    Daily disposable
    Silicone hydrogel contact lens
    Axis orientation
    Astigmatism
    Additional relevant MeSH terms:
    Astigmatism

    Study Results

    No Results Posted as of Aug 19, 2020