The Clinical Performance of Two Reusable Silicone Hydrogel Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 190
- Locations
- 15
- Primary Endpoint
- Least Squares Mean Distance VA With Study Lenses at Week 1
Study Overview
Brief Summary
The purpose of this study is to assess the clinical performance of two reusable silicone hydrogel contact lenses when worn on a daily wear basis.
Detailed Description
In this crossover study, subjects will wear each lens product for approximately 14 days and attend 7 scheduled visits. The expected overall duration of exposure to the study products is approximately 28 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- •Best Corrected Visual Acuity (BCVA) of 20/25 Snellen (0.10 logMAR) or better in each eye.
- •Willing to stop wearing habitual contact lenses for the duration of study participation.
- •Other protocol-specific 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.
- •Habitual wear of AOHP contact lenses.
- •Habitual wear of any daily disposable contact lenses.
- •Other protocol-specified exclusion criteria may apply.
Arms & Interventions
LID022821, then AOHP
Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.
Intervention: Serafilcon A contact lenses (Device)
LID022821, then AOHP
Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.
Intervention: Senofilcon A contact lenses (Device)
LID022821, then AOHP
Serafilcon A contact lenses worn first, with senofilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.
Intervention: CLEAR CARE (Device)
AOHP, then LID022821
Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.
Intervention: Serafilcon A contact lenses (Device)
AOHP, then LID022821
Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.
Intervention: Senofilcon A contact lenses (Device)
AOHP, then LID022821
Senofilcon A contact lenses worn first, with serafilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for approximately 14 days. CLEAR CARE will be used for daily cleaning and disinfection.
Intervention: CLEAR CARE (Device)
Outcomes
Primary Outcomes
Least Squares Mean Distance VA With Study Lenses at Week 1
Time Frame: Week 1 of each lens product worn during the corresponding crossover period
Visual acuity (VA) was assessed for each eye individually with study lenses in place using logarithmic of the Minimum Angle of Resolution (logMAR) reading charts. LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity.
Secondary Outcomes
No secondary outcomes reported