Approximately 340 participants (680 eyes) will be enrolled in this three-month, two-arm, 1:1 randomized, parallel-group, bilateral, double-masked study at approximately 22 investigative sites in the United States. Participants will be required to wear dispensed study lenses on a daily wear basis for three months with scheduled in-office replacement of study lenses at the 1-Month and 2-Month Follow-Up Visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
295
BL-3100-NBR03 multi-purpose solution used to clean and disinfect contact lenses
renu® Advanced Formula multi-purpose solution used to clean and disinfect contact lenses
Eric White OD Inc
San Diego, California, United States
Lee & Woo Optometry
San Francisco, California, United States
Overall Comfort Averaged Over All Follow-up Visits
Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response
Time frame: Assessed at all follow-up visits through 3 months.
Vision Averaged Over All Follow-up Visits
Vision will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response
Time frame: Assessed at all follow-up visits through 3 months.
The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits.
The degree of front surface deposits will be graded for each eye as: 0 - Absent, clean surface. 1. \- Very slight, only visible after tear film drying. 2. \- Slight, visible deposits easily removable. 3. \- Moderate, deposits adherent and not removable. 4. \- Severe, non-removable deposits and comfort affected.
Time frame: Assessed at all follow-up visits through 3 months.
The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits.
Graded slit-lamp findings will be assessed for each eye using Grades 0 through 4.
Time frame: Assessed at 3 months
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