Trial Outcomes & Findings for Bausch & Lomb Ophthalmic Viscosurgical Device (OVD) Dispersive (DVisc40) (NCT NCT03511638)

NCT ID: NCT03511638

Last Updated: 2021-10-22

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 372 participants
• Primary outcome timeframe: Day 90
• Results posted on: 2021-10-22

Participant Flow

Participant milestones

Measure	Bausch & Lomb DVisc40 Ophthalmic viscosurgical device Bausch \& Lomb DVisc40: Ophthalmic viscosurgical device	Alcon VISCOAT® Ophthalmic viscosurgical device Alcon VISCOAT®: Ophthalmic viscosurgical device
Overall Study STARTED	184	188
Overall Study COMPLETED	182	187
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bausch & Lomb Ophthalmic Viscosurgical Device (OVD) Dispersive (DVisc40)

Baseline characteristics by cohort

Measure	Bausch & Lomb DVisc40 n=184 Participants Ophthalmic viscosurgical device Bausch \& Lomb DVisc40: Ophthalmic viscosurgical device	Alcon VISCOAT® n=188 Participants Ophthalmic viscosurgical device Alcon VISCOAT®: Ophthalmic viscosurgical device	Total n=372 Participants Total of all reporting groups
Age, Continuous	70.0 years n=113 Participants	69.0 years n=163 Participants	70.0 years n=160 Participants
Sex: Female, Male Female	111 Participants n=113 Participants	120 Participants n=163 Participants	231 Participants n=160 Participants
Sex: Female, Male Male	73 Participants n=113 Participants	68 Participants n=163 Participants	141 Participants n=160 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=113 Participants	0 Participants n=163 Participants	1 Participants n=160 Participants
Race (NIH/OMB) Asian	39 Participants n=113 Participants	43 Participants n=163 Participants	82 Participants n=160 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=113 Participants	0 Participants n=163 Participants	0 Participants n=160 Participants
Race (NIH/OMB) Black or African American	19 Participants n=113 Participants	7 Participants n=163 Participants	26 Participants n=160 Participants
Race (NIH/OMB) White	122 Participants n=113 Participants	136 Participants n=163 Participants	258 Participants n=160 Participants
Race (NIH/OMB) More than one race	2 Participants n=113 Participants	2 Participants n=163 Participants	4 Participants n=160 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=113 Participants	0 Participants n=163 Participants	1 Participants n=160 Participants
Study eye - right or left Right Eye	91 Participants n=113 Participants	110 Participants n=163 Participants	201 Participants n=160 Participants
Study eye - right or left Left Eye	93 Participants n=113 Participants	78 Participants n=163 Participants	171 Participants n=160 Participants

PRIMARY outcome

Timeframe: Day 90

Population: Participants with epithelial cell density at baseline and Day 90 were included in the analysis.

Outcome measures

Measure	Bausch & Lomb DVisc40 n=168 Participants Ophthalmic viscosurgical device Bausch \& Lomb DVisc40: Ophthalmic viscosurgical device	Alcon VISCOAT® n=178 Participants Ophthalmic viscosurgical device Alcon VISCOAT®: Ophthalmic viscosurgical device
Percent Change in Mean Epithelial Cell Density (ECD)	-8.4 percentage change in ECD Standard Deviation 12.19	-6.8 percentage change in ECD Standard Deviation 12.54

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure	Bausch & Lomb DVisc40 n=184 Participants Ophthalmic viscosurgical device Bausch \& Lomb DVisc40: Ophthalmic viscosurgical device	Alcon VISCOAT® n=188 Participants Ophthalmic viscosurgical device Alcon VISCOAT®: Ophthalmic viscosurgical device
Percentage of Participants With Postoperative Intraocular Pressure of at Least 30 mm Hg	17.4 percentage of participants	20.3 percentage of participants

Adverse Events

Bausch & Lomb DVisc40

Serious events: 1 serious events

Other events: 48 other events

Deaths: 0 deaths

Alcon VISCOAT®

Serious events: 4 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bausch & Lomb DVisc40 n=184 participants at risk Ophthalmic viscosurgical device Bausch \& Lomb DVisc40: Ophthalmic viscosurgical device	Alcon VISCOAT® n=188 participants at risk Ophthalmic viscosurgical device Alcon VISCOAT®: Ophthalmic viscosurgical device
Eye disorders Posterior capsule rupture	0.00% 0/184 • 90 days	1.1% 2/188 • 90 days
Vascular disorders Aortic aneurysm	0.00% 0/184 • 90 days	0.53% 1/188 • 90 days
Injury, poisoning and procedural complications Cataract operation complication	0.00% 0/184 • 90 days	0.53% 1/188 • 90 days
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.54% 1/184 • 90 days	0.00% 0/188 • 90 days
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disorder	0.54% 1/184 • 90 days	0.00% 0/188 • 90 days
Vascular disorders Hypertension	0.00% 0/184 • 90 days	0.53% 1/188 • 90 days

Other adverse events

Measure	Bausch & Lomb DVisc40 n=184 participants at risk Ophthalmic viscosurgical device Bausch \& Lomb DVisc40: Ophthalmic viscosurgical device	Alcon VISCOAT® n=188 participants at risk Ophthalmic viscosurgical device Alcon VISCOAT®: Ophthalmic viscosurgical device
Eye disorders Punctate keratitis	9.2% 17/184 • 90 days	6.9% 13/188 • 90 days
Investigations Intraocular pressure increased	16.8% 31/184 • 90 days	20.2% 38/188 • 90 days

Additional Information

Study Director

Bausch & Lomb

Phone: 510-259-5284

Email: aloncaric@bauschhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee Please contact sponsor directly for details.
• Publication restrictions are in place

Restriction type: OTHER