Clinical Performance of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 106
- Locations
- 8
- Primary Endpoint
- Mean Binocular Visual Acuity at Distance (4 Meters) at Week 1
Study Overview
Brief Summary
The purpose of this study is to evaluate the on-eye multifocal clinical performance of investigational LID233309 contact lenses and Oasys multifocal (MF) contact lenses in a daily wear dispensing trial.
Detailed Description
Subjects will wear two different contact lens study products in a cross-over fashion. Each study product type will be worn for approximately 14 days. A washout period of 2-4 days will occur prior to the first wear period and between the two wear periods. Subjects will be expected to attend 7 office visits. The total duration of study participation is approximately 40 days with approximately 28 days of 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
- •Current wearer of biweekly/monthly replacement multifocal soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 6 months.
- •Manifest cylinder equal to or less than 0.75 diopter (D) in each eye.
- •Able to wear contact lenses within the available power range with a near ADD of +0.75 D to +2.50 D in each eye.
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Currently pregnant or lactating.
- •History of amblyopia, strabismus, or binocular vision abnormalities.
- •Habitual Oasys MF contact lens wearers or daily disposable contact lens wearers.
- •Monovision contact lens wearers and wearers of contact lens in one eye only.
- •Other protocol-defined exclusion criteria may apply.
Arms & Interventions
LID233309, then Oasys MF
Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.
Intervention: Serafilcon A multifocal contact lenses (Device)
LID233309, then Oasys MF
Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.
Intervention: Senofilcon A multifocal contact lenses (Device)
LID233309, then Oasys MF
Serafilcon A multifocal contact lenses worn in Period 1, followed by senofilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.
Intervention: CLEAR CARE® Cleaning & Disinfecting Solution (Device)
Oasys MF, then LID233309
Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.
Intervention: Serafilcon A multifocal contact lenses (Device)
Oasys MF, then LID233309
Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.
Intervention: Senofilcon A multifocal contact lenses (Device)
Oasys MF, then LID233309
Senofilcon A multifocal contact lenses worn in Period 1, followed by serafilcon A multifocal contact lenses worn in Period 2, as randomized. The study lenses will be worn in a daily wear mode in both eyes (bilaterally) during waking hours for at least 10 hours per day. Each wear period is 14 days (-0/+2). CLEAR CARE will be used for daily cleaning and disinfection.
Intervention: CLEAR CARE® Cleaning & Disinfecting Solution (Device)
Outcomes
Primary Outcomes
Mean Binocular Visual Acuity at Distance (4 Meters) at Week 1
Time Frame: Week 1 (Day 7 -0/+1 days) of each wear period. A wear period was 14 days (-0/+2 days) according to randomization assignment.
Visual Acuity (VA) was assessed at a distance of 4 meters with both eyes together (binocular) under high contrast, high illumination lighting with study lenses in place. VA was measured using letter charts and recorded in the logarithm of the minimum angle of resolution (LogMAR). A LogMAR value of 0 equates to 20/20 Snellen VA (normal distance eyesight), with negative LogMAR values representing better than 20/20 VA. The LogMAR VA scale ranges from -0.30 (20/10 Snellen) to 1.00 (20/200 Snellen). No hypothesis testing was pre-specified for this endpoint.
Secondary Outcomes
No secondary outcomes reported