Trial Outcomes & Findings for A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens (NCT NCT03897712)

Last Updated: 2022-11-14

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

84 participants

Primary outcome timeframe

Month 3

Results posted on

2022-11-14

Participant Flow

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Custom Samfilcon B Contact Lenses Participants will wear Bausch + Lomb investigational custom samfilcon B contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store their worn study lenses in a lens case filled with Biotrue multi-purpose solution (MPS). Custom Samfilcon B Contact Lenses: Contact lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.	Alden Optical HP Sphere Contact Lenses Participants will wear Alden Optical HP Sphere contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store worn study lenses in a lens case filled with Biotrue MPS. Alden Optical HP Sphere Contact Lens: Hioxifilcon D, 54% water, Alden Optical HP Sphere lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.
Overall Study STARTED	56 112	28 56
Overall Study COMPLETED	46 92	25 50
Overall Study NOT COMPLETED	10 20	3 6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Safety and Effectiveness of a Silicone Hydrogel Custom Contact Lens When Compared to Alden Optical HP Sphere Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Custom Samfilcon B Contact Lenses n=56 Participants Participants will wear Bausch + Lomb investigational custom samfilcon B contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store their worn study lenses in a lens case filled with Biotrue multi-purpose solution (MPS). Custom Samfilcon B Contact Lenses: Contact lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.	Alden Optical HP Sphere Contact Lenses n=28 Participants Participants will wear Alden Optical HP Sphere contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store worn study lenses in a lens case filled with Biotrue MPS. Alden Optical HP Sphere Contact Lens: Hioxifilcon D, 54% water, Alden Optical HP Sphere lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.	Total n=84 Participants Total of all reporting groups
Age, Continuous	31.8 years n=93 Participants	31.3 years n=4 Participants	31.5 years n=27 Participants
Sex: Female, Male Female	34 Participants n=93 Participants	18 Participants n=4 Participants	52 Participants n=27 Participants
Sex: Female, Male Male	22 Participants n=93 Participants	10 Participants n=4 Participants	32 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	8 Participants n=93 Participants	4 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) White	47 Participants n=93 Participants	23 Participants n=4 Participants	70 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: Month 3

Population: Randomized participants who attended 3-month visit and had no major protocol deviations.

Outcome measures

Outcome measures
Measure	Custom Samfilcon B Contact Lenses n=92 eyes Participants will wear Bausch + Lomb investigational custom samfilcon B contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store their worn study lenses in a lens case filled with Biotrue multi-purpose solution (MPS). Custom Samfilcon B Contact Lenses: Contact lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.	Alden Optical HP Sphere Contact Lenses n=42 eyes Participants will wear Alden Optical HP Sphere contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store worn study lenses in a lens case filled with Biotrue MPS. Alden Optical HP Sphere Contact Lens: Hioxifilcon D, 54% water, Alden Optical HP Sphere lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.
Mean Distance High-contrast logMAR Lens VA	-0.057 LogMAR Standard Deviation 0.0582	-0.059 LogMAR Standard Deviation 0.0590

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Custom Samfilcon B Contact Lenses n=112 eyes Participants will wear Bausch + Lomb investigational custom samfilcon B contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store their worn study lenses in a lens case filled with Biotrue multi-purpose solution (MPS). Custom Samfilcon B Contact Lenses: Contact lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.	Alden Optical HP Sphere Contact Lenses n=56 eyes Participants will wear Alden Optical HP Sphere contact lenses daily for 3 months. Participants will be provided with ReNu MultiPlus Lubricating and Rewetting Drops for use as needed during the study. Participants will store worn study lenses in a lens case filled with Biotrue MPS. Alden Optical HP Sphere Contact Lens: Hioxifilcon D, 54% water, Alden Optical HP Sphere lens ReNu MultiPlus Lubricating and Rewetting Drops: For use as needed during the study. Biotrue Multi-Purpose Solution: For daily rinsing, cleaning, disinfecting, and storing their lenses in lens cases during the study.
Proportion Of Eyes With Grade >2 Slit Lamp Findings	1 eyes	0 eyes

Adverse Events

Custom Samfilcon B Contact Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Alden Optical HP Sphere Contact Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Johnson Varughese

Bausch & Lomb

Phone: 9089271162

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Please contact sponsor for details.
Publication restrictions are in place

Restriction type: OTHER