Status:
COMPLETED
Product Performance of a New Silicone Hydrogel Contact Lens
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Myopia
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
The objective of this study is to evaluate the product performance of kalifilcon A, compared to the Johnson \& Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens ...
Eligibility Criteria
Inclusion
- 18 to 40 years old on the date the ICF is signed and have capacity to provide voluntary informed consent.
- myopic and require lens correction from -0.50 to -6.00 Diopter (D) with 0.25 D steps, in each eye.
- correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution \[logMAR\]) or better (2 meters distance, high-contrast chart) in each eye.
- free of any anterior segment disorders.
- adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks.
- access to internet connection and personal email to send/receive emails.
- habitually wear either Alcon's Air Optix Aqua, Air Optix with HydraGlyde, Air Optix Night \& Day, Bausch + Lomb's PureVision 2, Bausch + Lomb ULTRA, CooperVision's Biofinity, Johnson \& Johnson Acuvue Oasys® with HydraClear™, or Acuvue Vita soft contact lenses.
Exclusion
- participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation.
- have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- have any systemic or ocular disease currently affecting ocular health in the Investigator's opinion may have an effect on ocular health during the course of the study.
- using any systemic, topical or topical ocular medications that will in the Investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses.
- refractive astigmatism of greater than 0.75 D in either eye.
- anisometropia (spherical equivalent) of greater than 2.00 D.
- amblyopic.
- have had any corneal surgery (e.g., refractive surgery).
Key Trial Info
Start Date :
July 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2019
Estimated Enrollment :
805 Patients enrolled
Trial Details
Trial ID
NCT04901897
Start Date
July 31 2019
End Date
October 9 2019
Last Update
July 8 2021
Active Locations (35)
Enter a location and click search to find clinical trials sorted by distance.
1
Bausch Site 433
Birmingham, Alabama, United States, 35216
2
Bausch Site 431
Scottsdale, Arizona, United States, 85254
3
Bausch Site 406
Azusa, California, United States, 91702
4
Bausch Site 430
Los Angeles, California, United States, 90013