Custom Samfilcon B Contact Lenses
DeviceContact lens
NCT Number: NCT03897712
This study is to evaluate the safety and efficacy of Bausch + Lomb custom samfilcon B (test) lens compared to the hioxifilcon D, 54% water, Alden Optical HP Sphere (control) lens when worn by participants who wear soft contact lens on a daily basis.
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Bausch Site 1, San Francisco, California, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Contact lens
Hioxifilcon D, 54% water, Alden Optical HP Sphere lens
Other names: Alden Optical® HP Sphere lens
For use as needed during the study.
Other names: Bausch + Lomb ReNu MultiPlus® Lubricating and Rewetting Drops
For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.
Other names: Bausch + Lomb Biotrue® MPS
Time frame: Month 3
Monocular distance high-contrast logarithm of the minimum angle of resolution (logMAR) lens visual acuity (VA) will be assessed at Week 1, Month 1, Month 2, and Month. For each eye LogMAR will be averaged at Week 1, Month 1, Month 2, and Month 3 visits, resulting in 1 value of "All Study" logMAR lens VA per eye.
Time frame: Month 3
Graded slit lamp findings will be assessed at Month 3. Each eye will be classified with respect to having 1 or more observations with Grade >2 (Yes, No) at any visit.
Criteria of each grade: 0=None, 1= Trace, 2= Mild, 3=Moderate, 4= Severe. Higher grades are worse outcomes.
Bausch & Lomb Incorporated
Industry
A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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