Trial Outcomes & Findings for A Multi-Center, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution (NCT NCT02756624)

Last Updated: 2017-09-11

Results Overview

Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

516 participants

Primary outcome timeframe

Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation

Results posted on

2017-09-11

Participant Flow

Subjects were recruited from six sites in the US.

There were 516 subjects enrolled, 23 subjects discontinued, and 493 subjects completed the study. Participant flow and baseline characteristics are presented for the 516 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or AC-170 Vehicle.

Participant milestones

Participant milestones
Measure	AC-170 0.24% 1 drop in each eye 3 times daily for up to 6 weeks AC-170 0.24%	AC-170 Vehicle 1 drop in each eye 3 times daily for up to 6 weeks AC-170 Vehicle
Overall Study STARTED	343	173
Overall Study COMPLETED	327	166
Overall Study NOT COMPLETED	16	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multi-Center, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AC-170 0.24% n=343 Participants 1 drop in each eye 3 times daily for up to 6 weeks AC-170 0.24%	AC-170 Vehicle n=173 Participants 1 drop in each eye 3 times daily for up to 6 weeks AC-170 Vehicle	Total n=516 Participants Total of all reporting groups
Age, Continuous	32.5 years STANDARD_DEVIATION 16.81 • n=5 Participants	31.8 years STANDARD_DEVIATION 18.3 • n=7 Participants	32.2 years STANDARD_DEVIATION 17.31 • n=5 Participants
Age, Customized 2-6 years old	18 participants n=5 Participants	12 participants n=7 Participants	31 participants n=5 Participants
Age, Customized 2 years old	6 participants n=5 Participants	8 participants n=7 Participants	14 participants n=5 Participants
Age, Customized 3 years old	5 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants
Age, Customized 7-12 years old	29 participants n=5 Participants	15 participants n=7 Participants	44 participants n=5 Participants
Age, Customized 4-12 years old	36 participants n=5 Participants	17 participants n=7 Participants	53 participants n=5 Participants
Age, Customized 13-17 years old	37 participants n=5 Participants	17 participants n=7 Participants	54 participants n=5 Participants
Age, Customized >/= 18 years old	259 participants n=5 Participants	129 participants n=7 Participants	388 participants n=5 Participants
Sex: Female, Male Female	197 Participants n=5 Participants	102 Participants n=7 Participants	299 Participants n=5 Participants
Sex: Female, Male Male	146 Participants n=5 Participants	71 Participants n=7 Participants	217 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	58 Participants n=5 Participants	40 Participants n=7 Participants	98 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	285 Participants n=5 Participants	133 Participants n=7 Participants	418 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	53 Participants n=5 Participants	32 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) White	270 Participants n=5 Participants	126 Participants n=7 Participants	396 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Region of Enrollment United States	343 participants n=5 Participants	173 participants n=7 Participants	516 participants n=5 Participants

PRIMARY outcome

Timeframe: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	AC-170 0.24% n=309 Participants 1 drop in each eye 3 times daily for up to 6 weeks AC-170 0.24%	AC-170 Vehicle n=152 Participants 1 drop in each eye 3 times daily for up to 6 weeks AC-170 Vehicle
Tolerability of AC 170 0.24% at Visit 1 (Day 1) Upon instillation	0.87 units on a scale Standard Deviation 1.435	0.50 units on a scale Standard Deviation 1.106
Tolerability of AC 170 0.24% at Visit 1 (Day 1) 30 seconds post-instillation	0.64 units on a scale Standard Deviation 1.181	0.42 units on a scale Standard Deviation 0.982
Tolerability of AC 170 0.24% at Visit 1 (Day 1) 1 minute post-instillation	0.42 units on a scale Standard Deviation 1.001	0.31 units on a scale Standard Deviation 0.822

PRIMARY outcome

Timeframe: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	AC-170 0.24% n=299 Participants 1 drop in each eye 3 times daily for up to 6 weeks AC-170 0.24%	AC-170 Vehicle n=149 Participants 1 drop in each eye 3 times daily for up to 6 weeks AC-170 Vehicle
Tolerability of AC 170 0.24% at Visit 2 (Day 8) Upon instillation	0.65 units on a scale Standard Deviation 1.279	0.19 units on a scale Standard Deviation 0.665
Tolerability of AC 170 0.24% at Visit 2 (Day 8) 30 seconds post-instillation	0.38 units on a scale Standard Deviation 0.872	0.24 units on a scale Standard Deviation 0.766
Tolerability of AC 170 0.24% at Visit 2 (Day 8) 1 minute post-instillation	0.26 units on a scale Standard Deviation 0.801	0.21 units on a scale Standard Deviation 0.650

PRIMARY outcome

Timeframe: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation

Population: Intent to Treat (ITT)

Outcome measures

Outcome measures
Measure	AC-170 0.24% n=295 Participants 1 drop in each eye 3 times daily for up to 6 weeks AC-170 0.24%	AC-170 Vehicle n=148 Participants 1 drop in each eye 3 times daily for up to 6 weeks AC-170 Vehicle
Tolerability of AC 170 0.24% at Visit 3 (Day 22) Upon instillation	0.66 units on a scale Standard Deviation 1.321	0.43 units on a scale Standard Deviation 1.036
Tolerability of AC 170 0.24% at Visit 3 (Day 22) 30 seconds post-instillation	0.37 units on a scale Standard Deviation 0.942	0.25 units on a scale Standard Deviation 0.725
Tolerability of AC 170 0.24% at Visit 3 (Day 22) 1 minute post-instillation	0.24 units on a scale Standard Deviation 0.715	0.14 units on a scale Standard Deviation 0.446

PRIMARY outcome

Timeframe: up to 12 weeks

Population: Intent to Treat (ITT)

Adverse events will be measured through study completion

Outcome measures

Outcome measures
Measure	AC-170 0.24% n=343 Participants 1 drop in each eye 3 times daily for up to 6 weeks AC-170 0.24%	AC-170 Vehicle n=173 Participants 1 drop in each eye 3 times daily for up to 6 weeks AC-170 Vehicle
Number of Treatment Related Adverse Events	27 adverse events	15 adverse events

Adverse Events

AC-170 0.24%

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

AC-170 Vehicle

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AC-170 0.24% n=343 participants at risk 1 drop in each eye 3 times daily for up to 6 weeks AC-170 0.24%	AC-170 Vehicle n=173 participants at risk 1 drop in each eye 3 times daily for up to 6 weeks AC-170 Vehicle
Psychiatric disorders Substance abuse	0.29% 1/343 • Number of events 1 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.	0.00% 0/173 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
Gastrointestinal disorders Gastroesophageal reflux disease	0.29% 1/343 • Number of events 1 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.	0.00% 0/173 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.

Other adverse events

Other adverse events
Measure	AC-170 0.24% n=343 participants at risk 1 drop in each eye 3 times daily for up to 6 weeks AC-170 0.24%	AC-170 Vehicle n=173 participants at risk 1 drop in each eye 3 times daily for up to 6 weeks AC-170 Vehicle
Eye disorders Visual acuity reduced	1.2% 4/343 • Number of events 5 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.	2.3% 4/173 • Number of events 4 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
Eye disorders Conjunctival hyperemia	1.2% 4/343 • Number of events 4 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.	1.7% 3/173 • Number of events 3 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
Eye disorders Punctate keratitis	0.87% 3/343 • Number of events 3 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.	1.7% 3/173 • Number of events 3 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
General disorders Instillation site pain	1.7% 6/343 • Number of events 7 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.	0.58% 1/173 • Number of events 1 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
General disorders Instillation site erythema	0.00% 0/343 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.	1.2% 2/173 • Number of events 2 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
Infections and infestations Pharyngitis streptococcal	0.58% 2/343 • Number of events 2 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.	0.00% 0/173 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
Infections and infestations Sinusitis	0.29% 1/343 • Number of events 1 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.	0.58% 1/173 • Number of events 1 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.58% 2/343 • Number of events 2 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.	0.00% 0/173 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
Nervous system disorders Headache	0.58% 2/343 • Number of events 2 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.	0.00% 0/173 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.
Nervous system disorders Migraine	0.29% 1/343 • Number of events 1 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.	0.58% 1/173 • Number of events 1 • Adverse events were collected for the duration of the study. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited or observed.

Additional Information

Michael V.W. Bergamini, PhD - Chief Scientific Officer/Executive Vice President

Nicox Ophthalmics Inc.

Phone: 817-529-9315

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place