Contact Lens WearNCT04175340
A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop
A study testing BL-300-PFM04 and OPTI-FREE in people with Contact Lens Wear, run by Bausch & Lomb Incorporated at 15 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Wear
- What is being tested?
- BL-300-PFM04 and OPTI-FREE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 15 sitesUnited States
- Study dates
- 7 Nov 2019to 17 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Bausch Site 110
Bloomington, Kansas, 61704
Bausch Site 115
Brentwood, Tennessee, 37027
Bausch Site 104
Decatur, Georgia, 30035
Bausch Site 109
Edina, Minnesota, 55436
Bausch Site 114
Grants Pass, Oregon, 97526
Bausch Site 102
Jamestown, New York, 14701
Bausch Site 112
Leavenworth, Kansas, 66048
Bausch Site 101
Miamisburg, Ohio, 45342
Bausch Site 103
Nashville, Tennessee, 37205
Bausch Site 107
Portland, Maine, 04101
Bausch Site 108
San Francisco, California, 94112
Bausch Site 106
Sarasota, Florida, 34237
Bausch Site 111
Torrance, California, 90503
Bausch Site 113
Vestal, New York, 13850
Bausch Site 105
West Chester, Ohio, 45069
About this study
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.
- Conditions
- Contact Lens Wear
- Being tested
- BL-300-PFM04, OPTI-FREE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-300-PFM04Device
Preservative Free Lubricating and Rewetting Drops for use during contact lens wear
OPTI-FREEDevice
Replenish Rewetting Drops
| Study group | Role | What they receive |
|---|---|---|
| BL-300-PFM04 | Experimental | Not described Receives: Device: BL-300-PFM04 |
| Lubricating and rewetting drops | Active comparator | Not described Receives: Device: OPTI-FREE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start7 Nov 2019
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Contact Lens WearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175340
- Sponsor's protocol ID
- 952
- Status last verified
- Jun 2023
- First submitted
- 20 Nov 2019
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Effectiveness Study of a New Preservative Free Rewetting Drop
- ClinicalTrials.gov ID
- NCT04175340
- Acronym / sponsor ID
- 952
- Conditions
- Contact Lens Wear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BL-300-PFM04 | Experimental | Device: BL-300-PFM04 |
| Lubricating and rewetting drops | Active comparator | Device: OPTI-FREE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-300-PFM04Preservative Free Lubricating and Rewetting Drops for use during contact lens wear | Device | BL-300-PFM04 |
| OPTI-FREEReplenish Rewetting Drops | Device | Lubricating and rewetting drops |
Primary outcome
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 overall scheduled follow-up visits.
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.
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BL-300-PFM04 and OPTI-FREE in people with Contact Lens Wear, run by Bausch & Lomb Incorporated at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Comfort Averaged Over All Follow-up Visits (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.