Kalifilcon A Toric Compared to Commercially Available Lenses

December 5, 2024 updated by: Bausch & Lomb Incorporated

Orientation Characteristics of Kalifilcon A Daily Disposable Toric Contact Lenses Compared to Commercially Available Daily Disposable Toric Contact Lenses

Approximately thirty contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Approximately 30 soft toric contact lens adapted subjects will be enrolled in this feasibility, bilateral, randomized, double masked (subject and investigator masked), repeated measures insertion study. All subjects will be seen for a Screening/Dispensing Visit at which informed consent will be obtained and eligibility will be assessed. If study eligibility is met, subjects will have lenses inserted in random, successive order. Subjects will be receiving each of the study lens types once, in a randomized order. The subject will wear each of the study contact lenses for approximately 10 minutes.

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • United States
    • New York
      • Rochester, New York, United States, 14609
        • Bausch & Lomb, Incorporated

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

Yes

Description

Inclusion Criteria:

  1. Be 18 years or older on the date the Informed Consent Form (ICF) is signed and have capacity to read, understand and provide written voluntary informed consent.
  2. Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  3. Have no active ocular disease or allergic conjunctivitis.
  4. Not be using any topical ocular medications.
  5. Be willing and able to follow instructions.
  6. Have signed a statement of informed consent.

Exclusion Criteria:

  1. Participating in a conflicting study in the opinion of the Investigator.
  2. Considered by the Investigator to not be a suitable candidate for participation

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Kalifilcon A Daily Disposable Toric
Device: Kalifilcon Toric Lens
Kalifilcon A Daily Disposable Toric for Ametropia
Active Comparator: Total1 for Astigmatism
Device: Total1 for Astigmatism
Total1 for Astigmatism
Active Comparator: Precision1 for Astigmatism
Device: Precision1 for Astigmatism
Precision1 for Astigmatism
Active Comparator: MyDay Toric
Device: MyDay Toric
MyDay Toric

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Gaze Orientation for 5 Minutes
Time Frame: 5 minutes after lens insertion
Primary gaze orientation is measured in degrees using a slit lamp and reticule.
5 minutes after lens insertion

Collaborators and Investigators

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

Sponsor

Bausch & Lomb Incorporated

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)

September 5, 2023

Primary Completion (Actual)

September 27, 2023

Study Completion (Actual)

September 27, 2023

Study Registration Dates

First Submitted

September 29, 2023

First Submitted That Met QC Criteria

October 23, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Estimated)

December 10, 2024

Last Update Submitted That Met QC Criteria

December 5, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROC-23-007

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

Yes

product manufactured in and exported from the U.S.

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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