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NCT05129124 Clinical Trial

Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Astigmatism Clinical Trial

Official title:
Insertion Clinical Study to Evaluate the Orientation Characteristics of Multiple Kalifilcon A Daily Disposable Toric LD213001 Contact Lenses

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05129124
Other study ID # 21-012
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 30, 2021
Est. completion date January 13, 2022

Study information
Verified date March 2022
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective is to evaluate the fit characteristics (primary gaze orientation, rotational recovery, and movement) of kalifilcon A daily disposable toric lenses as compared to commercially available Ultra for Astigmatism lenses.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date January 13, 2022
Est. primary completion date January 13, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. 2. Considered by the Investigator to not be a suitable candidate for participation.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• kalifilcon A Daily Disposable Toric LD213001 Contact Lenses
kalifilcon A Daily Disposable Toric LD213001 Contact Lenses at different fittings
• Commercially available Ultra for Astigmatism Contact Lenses
Commercially available Ultra for Astigmatism Contact Lenses at different fittings

Locations
Country Name City State
United States Bausch and Lomb Site 01 Rochester New York

Sponsors (1)
Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Absolute Primary Gaze Orientation at 3 minutes for the lenses inserted at 90 degrees 3 minutes
See also
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Completed NCT05633082 - A Clinical Performance of Two Soft Toric Contact Lenses N/A
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Completed NCT02551796 - Early Changes Among FLEx, LASIK and FS-LASIK N/A
Completed NCT02555098 - A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens N/A
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Completed NCT02423109 - Bilateral Dispensing Study of Fanfilcon A Toric Versus Enfilcon A Toric Lenses N/A
Completed NCT02248766 - Clinical Performance of Habitual Wearers of Avaira Toric When Refitted With Clariti Toric Lenses N/A
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Completed NCT02624791 - Evaluating and Improving Functional Driving Vision of Patients With Astigmatism N/A
Withdrawn NCT01680354 - Surgical Correction of Astigmatism N/A
Completed NCT01207466 - Evaluation of Two Daily Disposable Contact Lenses for Wearers With Astigmatism N/A