Trial Outcomes & Findings for Safety and Efficacy of Vancomycin Ophthalmic Ointment in Patients With Moderate to Severe Bacterial Conjunctivitis (NCT NCT02432807)

NCT ID: NCT02432807

Last Updated: 2024-10-23

Results Overview

Between-group difference in clinical resolution of bacterial conjunctivitis (defined as absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection) at Day 8

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 303 participants
• Primary outcome timeframe: 8 days
• Results posted on: 2024-10-23

Participant Flow

Participant milestones

Measure	Vancomycin 1.1% Vancomycin hydrochloride ophthalmic ointment 1.1% dosed approximately 1 cm of ointment QID for 7 days Vancomycin 1.1%: Vancomycin hydrochloride ophthalmic ointment 1.1%	Placebo Vehicle (placebo) ophthalmic ointment dosed approximately 1 cm of ointment QID for 7 days Placebo: Placebo
Overall Study STARTED	152	151
Overall Study COMPLETED	149	147
Overall Study NOT COMPLETED	3	4

Reasons for withdrawal

Measure	Vancomycin 1.1% Vancomycin hydrochloride ophthalmic ointment 1.1% dosed approximately 1 cm of ointment QID for 7 days Vancomycin 1.1%: Vancomycin hydrochloride ophthalmic ointment 1.1%	Placebo Vehicle (placebo) ophthalmic ointment dosed approximately 1 cm of ointment QID for 7 days Placebo: Placebo
Overall Study Adverse Event	0	2
Overall Study Lost to Follow-up	1	0
Overall Study Withdrawal by Subject	1	1
Overall Study Other	1	1

Baseline Characteristics

Safety and Efficacy of Vancomycin Ophthalmic Ointment in Patients With Moderate to Severe Bacterial Conjunctivitis

Baseline characteristics by cohort

Measure	Vancomycin 1.1% n=152 Participants Vancomycin hydrochloride ophthalmic ointment 1.1% dosed approximately 1 cm of ointment QID for 7 days Vancomycin 1.1%: Vancomycin hydrochloride ophthalmic ointment 1.1%	Placebo n=151 Participants Vehicle (placebo) ophthalmic ointment dosed approximately 1 cm of ointment QID for 7 days Placebo: Placebo	Total n=303 Participants Total of all reporting groups
Age, Continuous	31.5 years STANDARD_DEVIATION 23.69 • n=93 Participants	31.9 years STANDARD_DEVIATION 26.73 • n=4 Participants	31.7 years STANDARD_DEVIATION 25.21 • n=27 Participants
Sex: Female, Male Female	95 Participants n=93 Participants	83 Participants n=4 Participants	178 Participants n=27 Participants
Sex: Female, Male Male	57 Participants n=93 Participants	68 Participants n=4 Participants	125 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	37 Participants n=93 Participants	39 Participants n=4 Participants	76 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	115 Participants n=93 Participants	112 Participants n=4 Participants	227 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	8 Participants n=93 Participants	5 Participants n=4 Participants	13 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Black or African American	8 Participants n=93 Participants	14 Participants n=4 Participants	22 Participants n=27 Participants
Race (NIH/OMB) White	134 Participants n=93 Participants	124 Participants n=4 Participants	258 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants
Region of Enrollment United States	152 participants n=93 Participants	151 participants n=4 Participants	303 participants n=27 Participants

PRIMARY outcome

Timeframe: 8 days

Population: Modified Intention to Treat population defined as all subjects with Gram positive bacterial conjunctivitis

Between-group difference in clinical resolution of bacterial conjunctivitis (defined as absence of conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection) at Day 8

Outcome measures

Measure	Vancomycin 1.1% n=83 Participants Vancomycin hydrochloride ophthalmic ointment 1.1% dosed approximately 1 cm of ointment QID for 7 days Vancomycin 1.1%: Vancomycin hydrochloride ophthalmic ointment 1.1%	Placebo n=76 Participants Vehicle (placebo) ophthalmic ointment dosed approximately 1 cm of ointment QID for 7 days Placebo: Placebo
Number of Subjects With Clinical Resolution of Bacterial Conjunctivitis	71 Participants	59 Participants

SECONDARY outcome

Timeframe: 8 days

Population: modified Intention to Treat population defined as all randomized subjects with Gram positive bacterial conjunctivitis

Between-group difference in microbial eradication (absence of all Gram-positive bacterial species present at or above the pathological threshold at baseline) at Day 8

Outcome measures

Measure	Vancomycin 1.1% n=81 Participants Vancomycin hydrochloride ophthalmic ointment 1.1% dosed approximately 1 cm of ointment QID for 7 days Vancomycin 1.1%: Vancomycin hydrochloride ophthalmic ointment 1.1%	Placebo n=74 Participants Vehicle (placebo) ophthalmic ointment dosed approximately 1 cm of ointment QID for 7 days Placebo: Placebo
Number of Subjects That Display Microbial Eradication	56 Participants	43 Participants

Adverse Events

Vancomycin 1.1%

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Vancomycin 1.1% n=152 participants at risk Vancomycin hydrochloride ophthalmic ointment 1.1% dosed approximately 1 cm of ointment QID for 7 days Vancomycin 1.1%: Vancomycin hydrochloride ophthalmic ointment 1.1%	Placebo n=151 participants at risk Vehicle (placebo) ophthalmic ointment dosed approximately 1 cm of ointment QID for 7 days Placebo: Placebo
Metabolism and nutrition disorders Dehydration	0.00% 0/152 • 8 days of treatment	0.66% 1/151 • Number of events 1 • 8 days of treatment

Other adverse events

Measure	Vancomycin 1.1% n=152 participants at risk Vancomycin hydrochloride ophthalmic ointment 1.1% dosed approximately 1 cm of ointment QID for 7 days Vancomycin 1.1%: Vancomycin hydrochloride ophthalmic ointment 1.1%	Placebo n=151 participants at risk Vehicle (placebo) ophthalmic ointment dosed approximately 1 cm of ointment QID for 7 days Placebo: Placebo
Eye disorders Dry eye	0.00% 0/152 • 8 days of treatment	1.3% 2/151 • Number of events 4 • 8 days of treatment
Eye disorders Punctate keratitis	1.3% 2/152 • Number of events 3 • 8 days of treatment	1.3% 2/151 • Number of events 3 • 8 days of treatment
Gastrointestinal disorders Vomiting	0.00% 0/152 • 8 days of treatment	2.0% 3/151 • Number of events 3 • 8 days of treatment
General disorders Pyrexia	0.66% 1/152 • Number of events 1 • 8 days of treatment	2.0% 3/151 • Number of events 3 • 8 days of treatment
Nervous system disorders Headache	1.3% 2/152 • Number of events 2 • 8 days of treatment	2.6% 4/151 • Number of events 4 • 8 days of treatment
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/152 • 8 days of treatment	1.3% 2/151 • Number of events 2 • 8 days of treatment

Additional Information

Mark Jasek

Eyevance Pharmaceuticals

Phone: 817-677-6127

Email: mjasek@eyevance.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place