Trial Outcomes & Findings for Brinzolamide/Brimonidine Combination vs Brimonidine 0.2% in the Prevention of IOP Rise After Nd-YAG Laser Capsulotomy (NCT NCT03192826)

NCT ID: NCT03192826

Last Updated: 2019-07-16

Results Overview

Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

79 participants

Primary outcome timeframe

1 hour

Results posted on

2019-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	Brinzolamide/Brimonidine FC 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy	Brimonidine 0.2% 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy	Artificial Tears 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
Overall Study STARTED	27	27	25
Overall Study COMPLETED	27	27	25
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brinzolamide/Brimonidine Combination vs Brimonidine 0.2% in the Prevention of IOP Rise After Nd-YAG Laser Capsulotomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brinzolamide/Brimonidine FC n=27 Participants 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy	Brimonidine 0.2% n=27 Participants 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy	Artificial Tears n=25 Participants 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy	Total n=79 Participants Total of all reporting groups
Age, Continuous	63.9 years STANDARD_DEVIATION 6.3 • n=5 Participants	65.2 years STANDARD_DEVIATION 6.0 • n=7 Participants	67.6 years STANDARD_DEVIATION 3.9 • n=5 Participants	65.5 years STANDARD_DEVIATION 5.8 • n=4 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	11 Participants n=7 Participants	13 Participants n=5 Participants	37 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	16 Participants n=7 Participants	12 Participants n=5 Participants	42 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants	27 Participants n=7 Participants	25 Participants n=5 Participants	79 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment Greece	27 participants n=5 Participants	27 participants n=7 Participants	25 participants n=5 Participants	79 participants n=4 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP

Comparison of intraocular pressure at 1 hour after Nd-YAG posterior capsulotomy compared to Baseline IOP

Outcome measures

Outcome measures
Measure	Brinzolamide/Brimonidine FC n=27 Participants 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy	Brimonidine 0.2% n=27 Participants 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy	Artificial Tears n=25 Participants 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy Baseline	15.6 mmHg Standard Deviation 1.5	15.7 mmHg Standard Deviation 1.5	15.2 mmHg Standard Deviation 1.9
Intraocular Pressure (IOP) at 1 Hour After Nd-YAG Posterior Capsulotomy 1 hour	13.7 mmHg Standard Deviation 2.0	14.7 mmHg Standard Deviation 3.7	19.5 mmHg Standard Deviation 2.9

PRIMARY outcome

Timeframe: 3 hours

Population: Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP

Comparison of intraocular pressure at 3 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP

Outcome measures

Outcome measures
Measure	Brinzolamide/Brimonidine FC n=27 Participants 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy	Brimonidine 0.2% n=27 Participants 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy	Artificial Tears n=25 Participants 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy Baseline	15.6 mmHg Standard Deviation 1.5	15.7 mmHg Standard Deviation 1.5	15.2 mmHg Standard Deviation 1.9
Intraocular Pressure (IOP) at 3 Hours After Nd-YAG Posterior Capsulotomy 3 hours	12.7 mmHg Standard Deviation 1.5	14.7 mmHg Standard Deviation 3.7	19.5 mmHg Standard Deviation 2.9

PRIMARY outcome

Timeframe: 24 hours

Population: Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP

Comparison of intraocular pressure at 24 hours after Nd-YAG posterior capsulotomy compared to Baseline IOP

Outcome measures

Outcome measures
Measure	Brinzolamide/Brimonidine FC n=27 Participants 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy	Brimonidine 0.2% n=27 Participants 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy	Artificial Tears n=25 Participants 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy Baseline	15.6 mmHg Standard Deviation 1.5	15.7 mmHg Standard Deviation 1.5	15.2 mmHg Standard Deviation 1.9
Intraocular Pressure (IOP) at 24 Hourw After Nd-YAG Posterior Capsulotomy 24 hours	14.6 mmHg Standard Deviation 1.1	15.5 mmHg Standard Deviation 1.7	15.8 mmHg Standard Deviation 1.8

PRIMARY outcome

Timeframe: 1 week

Population: Comparison of intraocular pressure at 1 weekafter Nd-YAG posterior capsulotomy compared to Baseline IOP

Comparison of intraocular pressure at 1 week after Nd-YAG posterior capsulotomy compared to Baseline IOP

Outcome measures

Outcome measures
Measure	Brinzolamide/Brimonidine FC n=27 Participants 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy Brinzolamide/Brimonidine FC: 1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy	Brimonidine 0.2% n=27 Participants 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy Brimonidine 0.2%: 1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy	Artificial Tears n=25 Participants 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy Artificial tears: 1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy Baseline	15.6 mmHg Standard Deviation 1.5	15.7 mmHg Standard Deviation 1.5	15.2 mmHg Standard Deviation 1.9
Intraocular Pressure (IOP) at 1 Week After Nd-YAG Posterior Capsulotomy 1 week	15.5 mmHg Standard Deviation 1.1	15.3 mmHg Standard Deviation 1.5	15.6 mmHg Standard Deviation 1.7

Adverse Events

Brinzolamide/Brimonidine FC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brimonidine 0.2%

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Artificial Tears

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

OPHTHALMOLOGY PATRAS

Patras Medical School

Phone: 6975801961

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place