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

Alcon

Status: Completed

Conditions: Myopia; Astigmatism; Ametropia; Hyperopia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05959200

CLN109-C001

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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92 participants in 2 patient groups

LID226397, then AOfAHP

Other group

Description:

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.

Treatment:

Device: CLEAR CARE

Device: Senofilcon A toric contact lenses

Device: Serafilcon A toric contact lenses

AOfAHP, then LID226397

Other group

Description:

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.

Treatment:

Device: CLEAR CARE

Device: Senofilcon A toric contact lenses

Device: Serafilcon A toric contact lenses