Clinical Performance Evaluation of Two Frequent Replacement Silicone Hydrogel Multifocal Contact Lenses
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Other: 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. |
Device: Lehfilcon A multifocal contact lenses
Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia
Other Names:
Device: Lotrafilcon B multifocal contact lenses
Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia
Other Names:
Device: CLEAR CARE®
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
|
Other: 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. |
Device: Lehfilcon A multifocal contact lenses
Investigational frequent replacement soft contact lens indicated for the optical correction of presbyopia
Other Names:
Device: Lotrafilcon B multifocal contact lenses
Commercially available frequent replacement soft contact lens indicated for the optical correction of presbyopia
Other Names:
Device: CLEAR CARE®
Hydrogen peroxide-based contact lens cleaning and disinfecting solution
|
Outcome Measures
Primary Outcome Measures
- Binocular high contrast/high illumination visual acuity at distance [Day 30, each study lens type]
Visual acuity (VA) with the contact lenses in place will be assessed under high contrast, high illumination.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Able to understand and sign an informed consent form that has been approved by an Institutional Review Board.
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Willing and able to attend all study visits as required by the protocol.
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Willing to stop wearing habitual contact lenses for the duration of the study.
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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.
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Other protocol-specified inclusion criteria may apply.
Key Exclusion Criteria:
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Any eye infection, inflammation, abnormality, or disease (including systemic) that contraindicates contact lens wear, as determined by the Investigator.
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Any use of systemic or ocular medications for which contact lens wear could be contraindicated, as determined by the Investigator.
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History of refractive surgery or planning to have refractive surgery during the study.
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Current or history of pathologically dry eye.
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Currently pregnant or lactating.
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Other protocol-specified exclusion criteria may apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Alcon Investigator 6565 | Maitland | Florida | United States | 32751 |
2 | Alcon Investigator 6355 | Orlando | Florida | United States | 32803 |
3 | Alcon Investigator 6567 | Pittsburg | Kansas | United States | 66762 |
4 | Alcon Investigator 6583 | Eden Prairie | Minnesota | United States | 55344 |
5 | Alcon Investigator 6402 | Medina | Minnesota | United States | 55340 |
6 | Alcon Investigator 8046 | Granville | Ohio | United States | 43023 |
7 | Alcon Investigator 6401 | Warwick | Rhode Island | United States | 02888 |
8 | Alcon Investigator 6353 | Memphis | Tennessee | United States | 38111 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLN705-C001