Status:
COMPLETED
Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Lead Sponsor:
Alcon Research
Conditions:
Presbyopia
Eligibility:
All Genders
40+ years
Phase:
NA
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) afte...
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 ...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
May 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT05338333
Start Date
May 27 2022
End Date
September 1 2022
Last Update
September 13 2023
Active Locations (8)
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1
Kindred Optics at Maitland Vision
Maitland, Florida, United States, 32751
2
Vision Health Institute
Orlando, Florida, United States, 32803
3
Kannarr Eye Care LLC
Pittsburg, Kansas, United States, 66762
4
The Eye Doctors, Inc.
Eden Prairie, Minnesota, United States, 55344