Trial Outcomes & Findings for A Multi-Center Study Evaluating the Safety of AC-170 0.24% (NCT NCT02132169)

Last Updated: 2017-09-11

Results Overview

Tolerability was assessed upon instillation of study medication, at 30 seconds and 1 minute 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

512 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 four sites in the US.

There were 512 subjects enrolled, 24 subjects discontinued, and 488 subjects completed the study. Participant flow and baseline characteristics are presented for the 512 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or AC-170 0%.

Participant milestones

Participant milestones
Measure	AC-170 0.24% 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%	AC-170 0% 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
Overall Study STARTED	341	171
Overall Study COMPLETED	326	162
Overall Study NOT COMPLETED	15	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multi-Center Study Evaluating the Safety of AC-170 0.24%

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AC-170 0.24% n=341 Participants 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%	AC-170 0% n=171 Participants 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%	Total n=512 Participants Total of all reporting groups
Age, Continuous	34.9 years STANDARD_DEVIATION 19.36 • n=5 Participants	36.6 years STANDARD_DEVIATION 19.56 • n=7 Participants	35.4 years STANDARD_DEVIATION 19.42 • n=5 Participants
Age, Customized 2-6 years old	20 participants n=5 Participants	13 participants n=7 Participants	33 participants n=5 Participants
Age, Customized 7-12 years old	28 participants n=5 Participants	12 participants n=7 Participants	40 participants n=5 Participants
Age, Customized 13-17 years old	34 participants n=5 Participants	16 participants n=7 Participants	50 participants n=5 Participants
Age, Customized >/= 18 years old	259 participants n=5 Participants	130 participants n=7 Participants	389 participants n=5 Participants
Sex: Female, Male Female	195 Participants n=5 Participants	114 Participants n=7 Participants	309 Participants n=5 Participants
Sex: Female, Male Male	146 Participants n=5 Participants	57 Participants n=7 Participants	203 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	11 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	321 Participants n=5 Participants	160 Participants n=7 Participants	481 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	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 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
Race (NIH/OMB) Black or African American	23 Participants n=5 Participants	14 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) White	298 Participants n=5 Participants	149 Participants n=7 Participants	447 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	4 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment United States	341 participants n=5 Participants	171 participants n=7 Participants	512 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=341 Participants 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%	AC-170 0% n=171 Participants 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) Upon instillation	0.9 units on a scale Standard Deviation 1.36	0.5 units on a scale Standard Deviation 1.02
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) 30 seconds post-instillation	0.7 units on a scale Standard Deviation 1.25	0.3 units on a scale Standard Deviation 0.82
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) 1 minute post-instillation	0.6 units on a scale Standard Deviation 1.22	0.3 units on a scale Standard Deviation 0.75

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=341 Participants 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%	AC-170 0% n=171 Participants 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8) Upon instillation	0.8 units on a scale Standard Deviation 1.24	0.3 units on a scale Standard Deviation 0.80
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8) 30 seconds post-instillation	0.5 units on a scale Standard Deviation 1.02	0.3 units on a scale Standard Deviation 0.74
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8) 1 minute post-instillation	0.4 units on a scale Standard Deviation 0.90	0.2 units on a scale Standard Deviation 0.63

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=341 Participants 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%	AC-170 0% n=171 Participants 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22) Upon instillation	0.6 units on a scale Standard Deviation 1.13	0.2 units on a scale Standard Deviation 0.66
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22) 30 seconds post-instillation	0.4 units on a scale Standard Deviation 0.83	0.2 units on a scale Standard Deviation 0.51
Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22) 1 minute post-instillation	0.3 units on a scale Standard Deviation 0.80	0.1 units on a scale Standard Deviation 0.47

SECONDARY outcome

Timeframe: Up to 12 Weeks

Population: Intent to Treat (ITT)

Safety measures (adverse events) of AC 170 0.024% compared to its vehicle were measured at Visit 1-4 and 5 (for subset of patients).

Outcome measures

Outcome measures
Measure	AC-170 0.24% n=341 Participants 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%	AC-170 0% n=171 Participants 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
Safety of AC 170 0.024% Compared to Its Vehicle	70 adverse events	40 adverse events

Adverse Events

AC-170 0.24%

Serious events: 1 serious events

Other events: 65 other events

Deaths: 0 deaths

AC-170 0%

Serious events: 1 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	AC-170 0.24% n=341 participants at risk 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%	AC-170 0% n=171 participants at risk 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
Infections and infestations Herpes zoster	0.29% 1/341 • 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% 0/171 • 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.
Immune system disorders Anaphylactic shock	0.00% 0/341 • 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% 1/171 • 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.

Other adverse events

Other adverse events
Measure	AC-170 0.24% n=341 participants at risk 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0.24%	AC-170 0% n=171 participants at risk 1 drop in each eye 2 times daily for up to 6 weeks AC-170 0%
Eye disorders Conjunctival Hyperaemia	7.9% 27/341 • Number of events 29 • 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.	11.1% 19/171 • Number of events 20 • 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 Ocular Hyperaemia	2.9% 10/341 • Number of events 11 • 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.	1.8% 3/171 • 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 Vision Blurred	0.59% 2/341 • 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.	1.8% 3/171 • 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 Dry eye	0.29% 1/341 • 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.	1.8% 3/171 • 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 Visual acuity reduced	0.59% 2/341 • 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.	1.2% 2/171 • 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.
Eye disorders Eye discharge	0.29% 1/341 • 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.	1.2% 2/171 • 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.
General disorders Instillation Site Pain	5.9% 20/341 • Number of events 21 • 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.	1.8% 3/171 • 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.
Nervous system disorders Headache	0.59% 2/341 • 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.	1.2% 2/171 • 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.
Nervous system disorders Dizziness	0.00% 0/341 • 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% 2/171 • 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.

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