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

Not Applicable

Completed

• Conditions: Ametropia; Myopia; Astigmatism; Hyperopia
• Interventions: Device: Serafilcon A toric contact lenses; Device: Senofilcon A toric contact lenses; Device: CLEAR CARE

• Registration Number: NCT05959200
• Lead Sponsor: Alcon Research

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2023-07-13
• Study First Submitted QC: 2023-07-24
• Study First Posted: 2023-07-25
• Study Start: 2023-08-14
• Primary Completion: 2023-10-23
• Study Completion: 2023-10-23
• Status Verified: 2024-10
• Results First Submitted: 2024-10-15
• Results First Submitted QC: 2024-10-15
• Last Update Submitted: 2024-10-15
• Results First Posted: 2024-11-29
• Last Update Posted: 2024-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LID226397, then AOfAHP	Serafilcon A toric contact lenses	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.
AOfAHP, then LID226397	Serafilcon A toric contact lenses	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.
AOfAHP, then LID226397	CLEAR CARE	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.
LID226397, then AOfAHP	Senofilcon A toric contact lenses	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.
LID226397, then AOfAHP	CLEAR CARE	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.
AOfAHP, then LID226397	Senofilcon A toric contact lenses	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Lenses With Axis Orientation Within Plus or Minus 30 Degrees From the Intended Axis at 10 Minutes After Lens Insertion	Day 1 Dispense, 10 minutes after lens insertion, for each wear period. Each wear period is approximately 14 days according to randomization assignment.	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.

Trial Locations

Locations (7)

Dr. Elsa Pao, OD; 🇺🇸 Oakland, California, United States

Pacific Rims Optometry; 🇺🇸 San Francisco, California, United States

ProCare Vision Centers, Inc.; 🇺🇸 Granville, Ohio, United States

Drs. Giedd, P.A.; 🇺🇸 Maitland, Florida, United States

Vision Health Institute; 🇺🇸 Orlando, Florida, United States

Optometry Group, PLLC; 🇺🇸 Memphis, Tennessee, United States

Franklin Park Eye Center, PC; 🇺🇸 Franklin Park, Illinois, United States