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

NCT05959200 | Completed Results

• 1 other identifier: CLN109-C001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Ametropia; Myopia; Hyperopia; Astigmatism

Outcome Measures

Primary Outcomes (1)

• Percentage of Lenses With Axis Orientation Within Plus or Minus 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 \[-\]). No hypothesis testing was prespecified for this endpoint.

  Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days according to randomization assignment.

Study Arms (2)

LID226397, then AOfAHP

OTHER

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: Serafilcon A toric contact lenses; Device: Senofilcon A toric contact lenses; Device: CLEAR CARE

AOfAHP, then LID226397

OTHER

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: Serafilcon A toric contact lenses; Device: Senofilcon A toric contact lenses; Device: CLEAR CARE

Interventions

Serafilcon A toric contact lenses DEVICE

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)

Also known as: LID226397

AOfAHP, then LID226397; LID226397, then AOfAHP

Senofilcon A toric contact lenses DEVICE

Silicone hydrogel contact lenses for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism)

Also known as: ACUVUE® OASYS for ASTIGMATISM with HYDRACLEAR® PLUS, AOfAHP

AOfAHP, then LID226397; LID226397, then AOfAHP

CLEAR CARE DEVICE

Hydrogen peroxide-based contact lens cleaning and disinfecting solution

Also known as: CLEAR CARE® Cleaning and Disinfecting Solution

AOfAHP, then LID226397; LID226397, then AOfAHP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (7)

Dr. Elsa Pao, OD

Oakland, California, 94607, United States

Location

Pacific Rims Optometry

San Francisco, California, 94127, United States

Location

Drs. Giedd, P.A.

Maitland, Florida, 32751, United States

Location

Vision Health Institute

Orlando, Florida, 32803, United States

Location

Franklin Park Eye Center, PC

Franklin Park, Illinois, 60131, United States

Location

ProCare Vision Centers, Inc.

Granville, Ohio, 43023, United States

Location

Optometry Group, PLLC

Memphis, Tennessee, 38111, United States

Location

MeSH Terms

Conditions

Refractive Errors; Myopia; Hyperopia; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Sr. Clinical Project Lead, Vision Care
• Organization: Alcon Research, LLC

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Lead, CRD Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: July 25, 2023
• Study Start: August 14, 2023
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2023
• Last Updated: November 29, 2024
• Results First Posted: November 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)