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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05959200
Other study ID # CLN109-C001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 14, 2023
Est. completion date October 23, 2023

Study information

Verified date October 2023
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 92
Est. completion date October 23, 2023
Est. primary completion date October 23, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Serafilcon A toric contact lenses
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
Senofilcon A toric contact lenses
Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)
CLEAR CARE
Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Locations

Country Name City State
United States Franklin Park Eye Center, PC Franklin Park Illinois
United States ProCare Vision Centers, Inc. Granville Ohio
United States Drs. Giedd, P.A. Maitland Florida
United States Optometry Group, PLLC Memphis Tennessee
United States Dr. Elsa Pao, OD Oakland California
United States Vision Health Institute Orlando Florida
United States Pacific Rims Optometry San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of lenses with axis orientation within ± 30 degrees from the intended axis at 10 minutes after lens insertion 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.
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