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

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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

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

Trial contacts and locations

0

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Central trial contact

Alcon Call Center

Data sourced from clinicaltrials.gov

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