NCT04175340

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
369

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2019

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2020

Completed
4.4 years until next milestone

Results Posted

Study results publicly available

July 10, 2024

Completed
Last Updated

July 10, 2024

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

November 20, 2019

Results QC Date

August 31, 2023

Last Update Submit

June 13, 2024

Conditions

Contact Lens Wear

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

BL-300-PFM04

EXPERIMENTAL
Device: BL-300-PFM04

Lubricating and rewetting drops

ACTIVE COMPARATOR
Device: OPTI-FREE

Interventions

BL-300-PFM04DEVICE

Preservative Free Lubricating and Rewetting Drops for use during contact lens wear

BL-300-PFM04
OPTI-FREEDEVICE

Replenish Rewetting Drops

Lubricating and rewetting drops

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Bausch Site 108

San Francisco, California, 94112, United States

Location

Bausch Site 111

Torrance, California, 90503, United States

Location

Bausch Site 106

Sarasota, Florida, 34237, United States

Location

Bausch Site 104

Decatur, Georgia, 30035, United States

Location

Bausch Site 110

Bloomington, Kansas, 61704, United States

Location

Bausch Site 112

Leavenworth, Kansas, 66048, United States

Location

Bausch Site 107

Portland, Maine, 04101, United States

Location

Bausch Site 109

Edina, Minnesota, 55436, United States

Location

Bausch Site 102

Jamestown, New York, 14701, United States

Location

Bausch Site 113

Vestal, New York, 13850, United States

Location

Bausch Site 101

Miamisburg, Ohio, 45342, United States

Location

Bausch Site 105

West Chester, Ohio, 45069, United States

Location

Bausch Site 114

Grants Pass, Oregon, 97526, United States

Location

Bausch Site 115

Brentwood, Tennessee, 37027, United States

Location

Bausch Site 103

Nashville, Tennessee, 37205, United States

Location

Results Point of Contact

Title
Senior Manager, Clinical Trials
Organization
Bausch + Lomb Incorporated
Margaret.Swartzenberg@bausch.com
(585) 623-9588

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 25, 2019

Study Start

November 7, 2019

Primary Completion

February 17, 2020

Study Completion

February 17, 2020

Last Updated

July 10, 2024

Results First Posted

July 10, 2024

Record last verified: 2023-06

Locations

US(15)