- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04175340
A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop
June 8, 2023 updated by: Bausch & Lomb Incorporated
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
369
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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
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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
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Edina, Minnesota, United States, 55436
- Bausch Site 109
-
-
New York
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Jamestown, New York, United States, 14701
- Bausch Site 102
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Vestal, New York, United States, 13850
- Bausch Site 113
-
-
Ohio
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Miamisburg, Ohio, United States, 45342
- Bausch Site 101
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West Chester, Ohio, United States, 45069
- Bausch Site 105
-
-
Oregon
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Grants Pass, Oregon, United States, 97526
- Bausch Site 114
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-
Tennessee
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Brentwood, Tennessee, United States, 37027
- Bausch Site 115
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Nashville, Tennessee, United States, 37205
- Bausch Site 103
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BL-300-PFM04
|
Preservative Free Lubricating and Rewetting Drops for use during contact lens wear
|
Active Comparator: Lubricating and rewetting drops
|
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
Time Frame: 1 month
|
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 over all scheduled follow-up visits.
|
1 month
|
Dryness averaged over all follow-up visits
Time Frame: 1 month
|
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
Time Frame: 1 month
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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)
June 13, 2023
Last Update Submitted That Met QC Criteria
June 8, 2023
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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