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Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses

Sponsor
Alcon Research (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05959200
Collaborator
(none)
92
Enrollment
7
Locations
2
Arms
2
Anticipated Duration (Months)
13.1
Patients Per Site
6.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.

Condition or Disease Intervention/Treatment Phase
  • Device: Serafilcon A toric contact lenses
  • Device: Senofilcon A toric contact lenses
  • Device: CLEAR CARE
 N/A

Detailed Description

Subjects will be expected to attend 7 visits including a screening visit. The total duration of a subject's participation in the study will be approximately 40 days.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Toric Contact Lenses
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: LID226397, then AOfAHP

Serafilcon A toric contact lenses worn in Period 1, with senofilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.

Device: Serafilcon A toric contact lenses
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
Other Names:
  • LID226397

    • Device: Senofilcon A toric contact lenses
    Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
    Other Names:
  • ACUVUE® OASYS for ASTIGMATISM with HYDRACLEAR® PLUS
  • AOfAHP

    • Device: CLEAR CARE
    Hydrogen peroxide-based contact lens cleaning and disinfecting solution
    Other Names:
  • CLEAR CARE® Cleaning and Disinfecting Solution

    		•
    Other: AOfAHP, then LID226397

    Senofilcon A toric contact lenses worn in Period 1, with serafilcon A toric contact lenses worn in Period 2. Each product will be worn bilaterally (in both eyes) during waking hours for approximately 14 days. CLEAR CARE will be used for nightly contact lens cleaning and disinfection.

    Device: Serafilcon A toric contact lenses
    Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
    Other Names:
  • LID226397

    • Device: Senofilcon A toric contact lenses
    Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
    Other Names:
  • ACUVUE® OASYS for ASTIGMATISM with HYDRACLEAR® PLUS
  • AOfAHP

    • Device: CLEAR CARE
    Hydrogen peroxide-based contact lens cleaning and disinfecting solution
    Other Names:
  • CLEAR CARE® Cleaning and Disinfecting Solution

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of lenses with axis orientation within ± 30 degrees from the intended axis at 10 minutes after lens insertion [Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days.]

      The investigator will view the contact lens through a slit lamp (biomicroscope) and record the axis orientation (-179° to +180°) as the number of degrees away from the ideal location (90° axis) either positive or negative depending on the direction (nasal [+] or temporal [-]).

    Eligibility Criteria

    Criteria

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

    • Successful wearers of any commercial soft toric contact lenses (except AOfAHP and daily disposable lenses) in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.

    • Able to be fit with and wear contact lenses within the available range of sphere & cylinder power and axes.

    • Best corrected distance visual acuity greater than or equal to 20/25 Snellen (0.10 logMAR) in each eye as determined by manifest refraction at screening.

    • Other protocol-defined inclusion criteria may apply.

    Key Exclusion Criteria:

    • Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.

    • Habitual AOfAHP contact lens wearers and habitual daily disposable lens wearers (worn within last 3 months).

    • Other exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr. Elsa Pao, OD Oakland California United States 94607
    2 Pacific Rims Optometry San Francisco California United States 94127
    3 Drs. Giedd, P.A. Maitland Florida United States 32751
    4 Vision Health Institute Orlando Florida United States 32803
    5 Franklin Park Eye Center, PC Franklin Park Illinois United States 60131
    6 ProCare Vision Centers, Inc. Granville Ohio United States 43023
    7 Optometry Group, PLLC Memphis Tennessee United States 38111

    Sponsors and Collaborators

    • Alcon Research

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alcon Research
    ClinicalTrials.gov Identifier:
    NCT05959200
    Other Study ID Numbers:
    • CLN109-C001
    First Posted:
    Jul 25, 2023
    Last Update Posted:
    Jul 25, 2023
    Last Verified:
    Jul 1, 2023
    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:
    No
    Additional relevant MeSH terms:
    Astigmatism
    Hyperopia
    Refractive Errors

    Study Results

    No Results Posted as of Jul 25, 2023