Status:
COMPLETED
Evaluation of Soft Multifocal Lenses in Presbyopic Previous Contact Lens Wearers
Lead Sponsor:
Jennifer Fogt
Collaborating Sponsors:
Alcon Research
Conditions:
Presbyopia
Eligibility:
All Genders
38+ years
Phase:
NA
Brief Summary
To explore the wear experience in Dailies TOTAL1 Multifocal contact lenses in presbyopic adults who have previously dropped out of contact lens wear.
Detailed Description
The purpose of this study is to evaluate the wear experience of people with presbyopia who previously dropped out of contact lens wear when fit with a Delefilcon A soft lens multifocal lens. Investiga...
Eligibility Criteria
Inclusion
- Ability to give informed consent.
- Any gender.
- Any racial or ethnic origin.
- At least 38 years of age or older.
- Willing to spend time for the study. Three visits are required to complete the study, and additional follow up visits could be scheduled if needed.
- Subjects must have corrected distance visual acuity in both eyes equivalent to 20/25 or better at the screening visit.
- Spectacle sphere power range between +6.00 to -10.00.
- Previously dropped out of contact lens wear due to vision or vision and discomfort.
- Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the PI
Exclusion
- Current or active ocular inflammation or infection as determined by the Investigator.
- Astigmatism ≥ 1.00 D in either eye.
- History of previous eye surgery.
- Strabismus or binocular vision abnormalities that prevent completion of testing, at the discretion of the Investigator.
- Demonstration or history of corneal ectasia or keratoconus.
- Pregnant or lactating
Key Trial Info
Start Date :
October 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06053463
Start Date
October 6 2023
End Date
May 23 2024
Last Update
November 27 2024
Active Locations (2)
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1
The Ohio State University College of Optometry
Columbus, Ohio, United States, 43210
2
ProCare Vision Center
Granville, Ohio, United States, 43023