Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 101
- Locations
- 8
- Primary Endpoint
- Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses
Study Overview
Brief Summary
The primary objective of this study is to demonstrate noninferiority in visual acuity at distance when wearing the test contact lenses (LID210464) compared to the control contact lenses (AOHG MF) after 30 days of wear.
Detailed Description
Subjects will be expected to attend 4 office visits and will be dispensed study contact lenses (test lenses and control lenses) for a 30-day duration of bilateral wear for each study lens type (total of approximately 60 days of contact lens wear).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Able to understand and sign an informed consent form that has been approved by an Institutional Review Board.
- •Willing and able to attend all study visits as required by the protocol.
- •Willing to stop wearing habitual contact lenses for the duration of the study.
- •Currently wearing daily disposable and biweekly/monthly replacement multifocal soft contact lenses in both eyes at least 5 days per week and at least 8 hours per day for at least 3 months. AOHG MF wearers may be included.
- •Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- •Any eye infection, inflammation, abnormality, or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
- •Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
- •History of refractive surgery or planning to have refractive surgery during the study.
- •Current or history of pathologically dry eye.
- •Currently pregnant or lactating.
- •Other protocol-specified exclusion criteria may apply.
Arms & Interventions
LID210464, then AOHG MF
Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
Intervention: Lehfilcon A multifocal contact lenses (Device)
LID210464, then AOHG MF
Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
Intervention: Lotrafilcon B multifocal contact lenses (Device)
LID210464, then AOHG MF
Lehfilcon A multifocal contact lenses (LID210464) worn in Period 1, with lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
Intervention: CLEAR CARE® (Device)
AOHG MF, then LID210464
Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
Intervention: Lehfilcon A multifocal contact lenses (Device)
AOHG MF, then LID210464
Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
Intervention: Lotrafilcon B multifocal contact lenses (Device)
AOHG MF, then LID210464
Lotrafilcon B multifocal contact lenses (AOHG MF) worn in Period 1, with lehfilcon A multifocal contact lenses (LID210464) worn in Period 2, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 30 days. CLEAR CARE® will be used for nightly contact lens cleaning and disinfecting.
Intervention: CLEAR CARE® (Device)
Outcomes
Primary Outcomes
Least Squares Mean Binocular High Contrast/High Illumination Visual Acuity at Distance With Study Lenses
Time Frame: Day 30, each wear period. A wear period was approximately 30 days.
Visual acuity (VA) was assessed with study lenses in place under high contrast, high illumination. VA was collected for both eyes together using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.
Secondary Outcomes
No secondary outcomes reported