A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop

The objective of this study is to evaluate the safety and effectiveness of lubricating and rewetting drop (Test) compared to OPTI-FREE® Replenish® Rewetting Drops (Control) when used by habitual contact lens wearers to bilaterally lubricate and rewet soft (hydrophilic) contact lenses including silicone hydrogel contact lenses and gas permeable (silicone acrylate and fluoro silicone acrylate) contact lenses.

Study Overview

• Status: Completed
• Conditions: Contact Lens Wear
• Intervention / Treatment: Device: BL-300-PFM04; Device: OPTI-FREE

• Study Type: Interventional
• Enrollment (Actual): 369
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94112
      • Bausch Site 108
    • Torrance, California, United States, 90503
      • Bausch Site 111
  • Florida
    • Sarasota, Florida, United States, 34237
      • Bausch Site 106
  • Georgia
    • Decatur, Georgia, United States, 30035
      • Bausch Site 104
  • Kansas
    • Bloomington, Kansas, United States, 61704
      • Bausch Site 110
    • Leavenworth, Kansas, United States, 66048
      • Bausch Site 112
  • Maine
    • Portland, Maine, United States, 04101
      • Bausch Site 107
  • Minnesota
    • Edina, Minnesota, United States, 55436
      • Bausch Site 109
  • New York
    • Jamestown, New York, United States, 14701
      • Bausch Site 102
    • Vestal, New York, United States, 13850
      • Bausch Site 113
  • Ohio
    • Miamisburg, Ohio, United States, 45342
      • Bausch Site 101
    • West Chester, Ohio, United States, 45069
      • Bausch Site 105
  • Oregon
    • Grants Pass, Oregon, United States, 97526
      • Bausch Site 114
  • Tennessee
    • Brentwood, Tennessee, United States, 37027
      • Bausch Site 115
    • Nashville, Tennessee, United States, 37205
      • Bausch Site 103

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and have the capacity to provide voluntary informed consent
• Subjects must be habitual wearers of included contact lenses.
• Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
• Subjects must agree to wear their lenses on a daily wear basis for approximately 1 month.

Exclusion Criteria:

• Subjects participating in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BL-300-PFM04	Device: BL-300-PFM04; Preservative Free Lubricating and Rewetting Drops for use during contact lens wear
Active Comparator: Lubricating and rewetting drops	Device: OPTI-FREE; Replenish Rewetting Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. For each eye, mean overall comfort over all follow-up visits will be computed as the average of the non-missing values overall scheduled follow-up visits.	1 month
Dryness Averaged Over All Follow-up Visits	Dryness will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response. For each eye, mean dryness over all follow-up visits will be computed as the average of the non-missing values over all scheduled follow-up visits.	1 month
Proportion of Eyes With Slit Lamp Findings Greater Than Grade 2 at Any Follow-up Visit	At each follow-up visit, graded slit lamp findings will be assessed for each eye using Grades 0 through 4. Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than grade 2 at any visit (Absent, Present).	1 month

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2019
• Primary Completion (Actual): February 17, 2020
• Study Completion (Actual): February 17, 2020

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 10, 2024
• Last Update Submitted That Met QC Criteria: June 13, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 952

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No