Status:
COMPLETED
Clinical Characterization of an Investigational Frequent Replacement Daily Wear Silicone Hydrogel Sphere Contact Lens
Lead Sponsor:
Alcon Research
Conditions:
Refractive Errors
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The primary objective of this study is to evaluate the overall clinical performance of an investigational silicone hydrogel contact lens over 7 days of daily wear.
Detailed Description
Participants will attend a Screening visit, a Dispense visit, and a Week 1 Follow-up/exit visit.
Eligibility Criteria
Inclusion
- Understand and sign an Informed Consent that has been approved by an Institutional Review Board.
- Successful wear of spherical daily wear frequent replacement soft contact lenses in both eyes for a minimum of 5 days per week and 8 hours per day during the past 3 months.
- Willing to stop wearing habitual contact lenses for the duration of study participation.
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Any condition that contraindicates contact lens wear, as determined by the Investigator.
- Any use of systemic or ocular medications that contraindicates contact lens wear, as determined by the Investigator.
- History of refractive surgery or plan to have refractive surgery during the study.
- Current or history of dry eye in either eye that, in the opinion of the Investigator, would preclude contact lens wear.
- Wears habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
January 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2021
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04702984
Start Date
January 21 2021
End Date
February 26 2021
Last Update
March 16 2022
Active Locations (3)
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1
Alcon Investigator 6565
Maitland, Florida, United States, 32751
2
Alcon Investigator 6353
Memphis, Tennessee, United States, 38111
3
Alcon Investigator 8028
Wichita Falls, Texas, United States, 76308