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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05959200
• Other study ID #: CLN109-C001
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Ametropia
• Astigmatism
• Hyperopia
• Myopia
• Refractive Errors

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.