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

October 24, 2023 updated by: Alcon Research
The primary objective of this study is to evaluate the axis orientation of LID226397 toric contact lenses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94607
        • Dr. Elsa Pao, OD
      • San Francisco, California, United States, 94127
        • Pacific Rims Optometry
    • Florida
      • Maitland, Florida, United States, 32751
        • Drs. Giedd, P.A.
      • Orlando, Florida, United States, 32803
        • Vision Health Institute
    • Illinois
      • Franklin Park, Illinois, United States, 60131
        • Franklin Park Eye Center, PC
    • Ohio
      • Granville, Ohio, United States, 43023
        • Procare Vision Centers, Inc.
    • Tennessee
      • Memphis, Tennessee, United States, 38111
        • Optometry Group, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 14, 2023

Primary Completion (Actual)

October 23, 2023

Study Completion (Actual)

October 23, 2023

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

July 24, 2023

First Posted (Actual)

July 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 25, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN109-C001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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