Assessing Fitting Guides in Alcon Multifocal Contact Lenses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 188
- Locations
- 20
- Primary Endpoint
- Mean Number of Trial Lenses Needed to Fit Each Eye
Study Overview
Brief Summary
The purpose of this study is to compare an alternative fitting guide to a current fitting guide for optimizing contact lens parameters and determining contact lens prescription.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Masking Description
Subjects are unmasked to the study lenses that are dispensed, but will be masked to the fitting guides used to fit each eye.
Eligibility Criteria
- Ages
- 40 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Sign informed consent;
- •Normal eyes;
- •Current full-time soft contact lens wearer needing presbyopia correction;
- •Willing to wear lenses for a minimum of five days per week, six hours per day, and attend all study visits;
- •Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- •Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
- •Eye conditions (past or present) as specified in the protocol;
- •Currently wearing Alcon multifocal (MF) contact lenses;
- •Only one eye with functional vision;
- •Contact lens wear in one eye only;
- •Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
- •Other protocol-defined exclusion criteria may apply.
Arms & Interventions
AOA MF
Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 10 ± 3 days
Intervention: Lotrafilcon B multifocal contact lenses (Device)
DACP MF
Nelfilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
Intervention: Nelfilcon A multifocal contact lenses (Device)
DT1 MF
Delefilcon A multifocal contact lenses worn bilaterally for 10 ± 3 days
Intervention: Delefilcon A multifocal contact lenses (Device)
Outcomes
Primary Outcomes
Mean Number of Trial Lenses Needed to Fit Each Eye
Time Frame: VIsit 1/Day 1
The Investigator used a multi-focal contact lens fitting guide to determine which study lens to fit
Secondary Outcomes
No secondary outcomes reported