CataractNCT03511638
Bausch & Lomb Ophthalmic Viscosurgical Device (OVD) Dispersive (DVisc40)
A study testing Bausch & Lomb DVisc40 and Alcon VISCOAT® in people with Cataract, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD Read more about this study
- Who is it for?
- Ages 45 to 99 years
- Conditions the study is for
- Cataract
- What is being tested?
- Bausch & Lomb DVisc40 and Alcon VISCOAT®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 372 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2018to 1 Apr 2019
- 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 45 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject must be at least 45 years old and have a clinically documented diagnosis of age-related non-complicated cataract that is considered amenable to treatment with standard phacoemulsification cataract extraction and IOL implantation.
- 2. The subject must have the capability to provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
- 3. The subject must be willing and able to return for all scheduled follow-up examinations through 90 days following surgery.
- Study #877 Protocol DVisc40 28JUL2017 V1.0 CONFIDENTIAL Page 16 of 53 4. The subject must have clear intraocular media other than the cataract in the operative eye.
Who cannot join
- 1. The subject has participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
- 2. The subject has any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye.
- 3. The subject has anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation) in the operative eye.
- 4. The subject has any condition which prevents reliable specular microscopy in the operative eye.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
Read the detailed description
This is a multicenter, controlled, randomized, monocular trial evaluating the safety and effectiveness of the Bausch \& Lomb DVisc40 dispersive OVD compared to the Alcon VISCOAT® dispersive OVD when used in cataract surgery. Subjects will be randomized to one of the two treatment groups in a 1:1 ratio (DVisc40:VISCOAT®).
- Conditions
- Cataract
- Being tested
- Bausch & Lomb DVisc40, Alcon VISCOAT®
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bausch & Lomb DVisc40Device
Ophthalmic viscosurgical device
Alcon VISCOAT®Device
Ophthalmic viscosurgical device
| Study group | Role | What they receive |
|---|---|---|
| Bausch & Lomb DVisc40 | Experimental | Ophthalmic viscosurgical device Receives: Device: Bausch & Lomb DVisc40 |
| Alcon VISCOAT® | Active comparator | Ophthalmic viscosurgical device Receives: Device: Alcon VISCOAT® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Mean Epithelial Cell Density (ECD)
Measured: Day 90
Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2018
- Study start9 May 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
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 CataractStudies 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
- Model description
- a multicenter, controlled, randomized, monocular trial of Bausch \& Lomb DVisc40 (test) OVD compared to the currently marketed Alcon VISCOAT® (control) OVD
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anya Loncaric, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511638
- Sponsor's protocol ID
- S877
- Status last verified
- Sep 2021
- First submitted
- 17 Nov 2017
- Last updated
- 22 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
- ClinicalTrials.gov ID
- NCT03511638
- Acronym / sponsor ID
- S877
- Conditions
- Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 372 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 9 May 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 30 Apr 2018 (actual)
- Results
- Posted 22 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Study to Document the Safety and Effectiveness of a New OVD When Compared to a Control OVD
Detailed description
This is a multicenter, controlled, randomized, monocular trial evaluating the safety and effectiveness of the Bausch \& Lomb DVisc40 dispersive OVD compared to the Alcon VISCOAT® dispersive OVD when used in cataract surgery. Subjects will be randomized to one of the two treatment groups in a 1:1 ratio (DVisc40:VISCOAT®).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- a multicenter, controlled, randomized, monocular trial of Bausch \& Lomb DVisc40 (test) OVD compared to the currently marketed Alcon VISCOAT® (control) OVD
| Arm | Type | Receives |
|---|---|---|
| Bausch & Lomb DVisc40 | Experimental | Device: Bausch & Lomb DVisc40Ophthalmic viscosurgical device |
| Alcon VISCOAT® | Active comparator | Device: Alcon VISCOAT®Ophthalmic viscosurgical device |
Who may qualify
- Ages
- 45 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The subject must be at least 45 years old and have a clinically documented diagnosis of age-related non-complicated cataract that is considered amenable to treatment with standard phacoemulsification cataract extraction and IOL implantation.
- 2. The subject must have the capability to provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
- 3. The subject must be willing and able to return for all scheduled follow-up examinations through 90 days following surgery.
- Study #877 Protocol DVisc40 28JUL2017 V1.0 CONFIDENTIAL Page 16 of 53 4. The subject must have clear intraocular media other than the cataract in the operative eye.
Key exclusion criteria (4 listed)
- 1. The subject has participated in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
- 2. The subject has any corneal pathology (e.g., significant scarring, guttata, inflammation, edema, dystrophy, etc.) in the operative eye.
- 3. The subject has anterior segment pathology likely to increase the risk of an adverse outcome for phacoemulsification cataract surgery (e.g., pseudoexfoliation syndrome, synechiae, iris atrophy, inadequate dilation, shallow anterior chamber, traumatic cataract, lens subluxation) in the operative eye.
- 4. The subject has any condition which prevents reliable specular microscopy in the operative eye.
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 |
|---|---|---|
| Bausch & Lomb DVisc40Ophthalmic viscosurgical device | Device | Bausch & Lomb DVisc40 |
| Alcon VISCOAT®Ophthalmic viscosurgical device | Device | Alcon VISCOAT® |
Primary outcome
Percent Change in Mean Epithelial Cell Density (ECD)
Time frame: Day 90
Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- 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.
Anya Loncaric study director
Bausch Health Americas, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bausch & Lomb DVisc40 and Alcon VISCOAT® in people with Cataract, run by Bausch & Lomb Incorporated at 1 site 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 4 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 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 22 Oct 2021). 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?
Percent Change in Mean Epithelial Cell Density (ECD) (time frame: Day 90). The study lists 2 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 22 Oct 2021.