Trial Outcomes & Findings for A Multi-Center, Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle (NCT NCT01881113)

NCT ID: NCT01881113

Last Updated: 2017-11-09

Results Overview

A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 101 participants
• Primary outcome timeframe: 3, 5, 7 minutes post-CAC
• Results posted on: 2017-11-09

Participant Flow

Subjects were recruited from three sites in the US.

There were 101 subjects enrolled, 14 subjects discontinued, and 87 subjects completed the study. Participant flow and baseline characteristics are presented for the 101 subjects that met all inclusion criteria and none of the exclusion criteria and were randomized to receive AC-170 0.24% or Vehicle.

Participant milestones

Measure	AC-170 0.24% AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Overall Study STARTED	51	50
Overall Study COMPLETED	43	44
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Multi-Center, Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle

Baseline characteristics by cohort

Measure	AC-170 0.24% n=51 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=50 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period	Total n=101 Participants Total of all reporting groups
Age, Continuous	40.6 years STANDARD_DEVIATION 12.8 • n=5 Participants	39.2 years STANDARD_DEVIATION 10.84 • n=7 Participants	39.9 years STANDARD_DEVIATION 11.84 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	20 Participants n=7 Participants	32 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	30 Participants n=7 Participants	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	50 Participants n=5 Participants	50 Participants n=7 Participants	100 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 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	10 Participants n=5 Participants	17 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants	31 Participants n=7 Participants	72 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants	50 participants n=7 Participants	101 participants n=5 Participants

PRIMARY outcome

Timeframe: 3, 5, 7 minutes post-CAC

Population: Intent to Treat (ITT)

A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=51 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=50 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-Dose) 3 minutes post-CAC	1.94 units on a scale Standard Deviation 0.933	2.86 units on a scale Standard Deviation 0.748
Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-Dose) 5 minutes post-CAC	2.03 units on a scale Standard Deviation 0.947	2.94 units on a scale Standard Deviation 0.712
Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-Dose) 7 minutes post-CAC	1.82 units on a scale Standard Deviation 1.026	2.66 units on a scale Standard Deviation 0.809

PRIMARY outcome

Timeframe: 3, 5, 7 minutes post-CAC

Population: Intent to Treat (ITT)

A treatment efficacy CAC was performed 15 minutes after drop instillation. Ocular itching was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ocular itching score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=51 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=50 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Ocular Itching at Onset of Action (15 Minutes Post-Dose) 3 minutes post-CAC	1.01 units on a scale Standard Deviation 1.006	2.54 units on a scale Standard Deviation 0.943
Ocular Itching at Onset of Action (15 Minutes Post-Dose) 5 minutes post-CAC	1.17 units on a scale Standard Deviation 1.002	2.51 units on a scale Standard Deviation 0.875
Ocular Itching at Onset of Action (15 Minutes Post-Dose) 7 minutes post-CAC	1.15 units on a scale Standard Deviation 1.006	2.23 units on a scale Standard Deviation 0.956

PRIMARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT)

A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=51 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=50 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose) 7 minutes post-CAC	1.97 units on a scale Standard Deviation 0.702	2.39 units on a scale Standard Deviation 0.619
Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose) 15 minutes post-CAC	2.13 units on a scale Standard Deviation 0.639	2.38 units on a scale Standard Deviation 0.602
Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose) 20 minutes post-CAC	2.09 units on a scale Standard Deviation 0.701	2.40 units on a scale Standard Deviation 0.639

PRIMARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT)

A treatment efficacy CAC was performed 15 minutes after drop instillation. Conjunctival Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of conjunctival redness score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=51 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=50 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Conjunctival Redness at Onset of Action (15 Minutes Post-Dose) 7 minutes post-CAC	1.92 units on a scale Standard Deviation 0.713	2.38 units on a scale Standard Deviation 0.653
Conjunctival Redness at Onset of Action (15 Minutes Post-Dose) 15 minutes post-CAC	2.19 units on a scale Standard Deviation 0.608	2.37 units on a scale Standard Deviation 0.661
Conjunctival Redness at Onset of Action (15 Minutes Post-Dose) 20 minutes post-CAC	2.15 units on a scale Standard Deviation 0.646	2.41 units on a scale Standard Deviation 0.651

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=50 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=48 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Ciliary Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose) 7 minutes post-CAC	1.71 units on a scale Standard Deviation 0.794	2.15 units on a scale Standard Deviation 0.689
Ciliary Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose) 15 minutes post-CAC	1.93 units on a scale Standard Deviation 0.753	2.05 units on a scale Standard Deviation 0.777
Ciliary Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose) 20 minutes post-CAC	1.87 units on a scale Standard Deviation 0.801	2.19 units on a scale Standard Deviation 0.659

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 15 minutes after drop instillation. Ciliary Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of ciliary redness score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=43 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=44 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Ciliary Redness at Onset of Action (15 Minutes Post-Dose) 7 minutes post-CAC	1.62 units on a scale Standard Deviation 0.945	2.29 units on a scale Standard Deviation 0.803
Ciliary Redness at Onset of Action (15 Minutes Post-Dose) 15 minutes post-CAC	2.05 units on a scale Standard Deviation 0.793	2.34 units on a scale Standard Deviation 0.780
Ciliary Redness at Onset of Action (15 Minutes Post-Dose) 20 minutes post-CAC	2.09 units on a scale Standard Deviation 0.779	2.36 units on a scale Standard Deviation 0.784

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=50 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=48 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose) 7 minutes post-CAC	1.92 units on a scale Standard Deviation 0.662	2.29 units on a scale Standard Deviation 0.567
Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose) 15 minutes post-CAC	2.08 units on a scale Standard Deviation 0.663	2.27 units on a scale Standard Deviation 0.605
Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose) 20 minutes post-CAC	2.06 units on a scale Standard Deviation 0.689	2.30 units on a scale Standard Deviation 0.640

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 15 minutes after drop instillation. Episcleral Redness was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of episcleral redness score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=43 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=44 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Episcleral Redness at Onset of Action (15 Minutes Post-Dose) 20 minutes post-CAC	2.18 units on a scale Standard Deviation 0.655	2.36 units on a scale Standard Deviation 0.604
Episcleral Redness at Onset of Action (15 Minutes Post-Dose) 7 minutes post-CAC	1.91 units on a scale Standard Deviation 0.798	2.31 units on a scale Standard Deviation 0.575
Episcleral Redness at Onset of Action (15 Minutes Post-Dose) 15 minutes post-CAC	2.22 units on a scale Standard Deviation 0.645	2.32 units on a scale Standard Deviation 0.582

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=50 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=48 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Chemosis at Duration of Action (8 Hours + 30 Minutes Post-Dose) 7 minutes post-CAC	0.63 units on a scale Standard Deviation 0.540	0.96 units on a scale Standard Deviation 0.666
Chemosis at Duration of Action (8 Hours + 30 Minutes Post-Dose) 15 minutes post-CAC	0.89 units on a scale Standard Deviation 0.627	1.28 units on a scale Standard Deviation 0.773
Chemosis at Duration of Action (8 Hours + 30 Minutes Post-Dose) 20 minutes post-CAC	0.95 units on a scale Standard Deviation 0.753	1.27 units on a scale Standard Deviation 0.785

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 15 minutes after drop instillation. Chemosis was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of chemosis score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=43 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=44 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Chemosis at Onset of Action (15 Minutes Post-Dose) 20 minutes post-CAC	0.67 units on a scale Standard Deviation 0.626	0.85 units on a scale Standard Deviation 0.702
Chemosis at Onset of Action (15 Minutes Post-Dose) 7 minutes post-CAC	0.35 units on a scale Standard Deviation 0.387	0.58 units on a scale Standard Deviation 0.519
Chemosis at Onset of Action (15 Minutes Post-Dose) 15 minutes post-CAC	0.59 units on a scale Standard Deviation 0.585	0.75 units on a scale Standard Deviation 0.671

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=50 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=48 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-Dose) 15 minutes post-CAC	0.8 units on a scale Standard Deviation 0.71	1.4 units on a scale Standard Deviation 0.80
Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-Dose) 20 minutes post-CAC	0.9 units on a scale Standard Deviation 0.91	1.4 units on a scale Standard Deviation 0.89
Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-Dose) 7 minutes post-CAC	0.7 units on a scale Standard Deviation 0.70	1.4 units on a scale Standard Deviation 0.78

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 15 minutes after drop instillation. Eyelid swelling was assessed by the patient on a 0-3 scale (0=none to 3=severe). Average of eyelid swelling score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=43 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=44 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Eyelid Swelling at Onset of Action (15 Minutes Post-Dose) 7 minutes post-CAC	0.4 units on a scale Standard Deviation 0.67	1.2 units on a scale Standard Deviation 0.63
Eyelid Swelling at Onset of Action (15 Minutes Post-Dose) 15 minutes post-CAC	0.5 units on a scale Standard Deviation 0.76	1.3 units on a scale Standard Deviation 0.75
Eyelid Swelling at Onset of Action (15 Minutes Post-Dose) 20 minutes post-CAC	0.4 units on a scale Standard Deviation 0.70	1.2 units on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=50 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=48 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Tearing at Duration of Action (8 Hours + 30 Minutes Post-Dose) 7 minutes post-CAC	0.8 units on a scale Standard Deviation 0.67	1.2 units on a scale Standard Deviation 0.81
Tearing at Duration of Action (8 Hours + 30 Minutes Post-Dose) 15 minutes post-CAC	0.8 units on a scale Standard Deviation 0.90	1.2 units on a scale Standard Deviation 0.94
Tearing at Duration of Action (8 Hours + 30 Minutes Post-Dose) 20 minutes post-CAC	0.9 units on a scale Standard Deviation 0.98	1.0 units on a scale Standard Deviation 1.01

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 15 minutes after drop instillation. Tearing was assessed by the patient on a 0-4 scale (0=none to 4=severe). Average of tearing score over both eyes was analyzed.

Outcome measures

Measure	AC-170 0.24% n=43 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=44 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Tearing at Onset of Action (15 Minutes Post-Dose) 7 minutes post-CAC	0.5 units on a scale Standard Deviation 0.61	1.1 units on a scale Standard Deviation 0.89
Tearing at Onset of Action (15 Minutes Post-Dose) 15 minutes post-CAC	0.5 units on a scale Standard Deviation 0.62	1.1 units on a scale Standard Deviation 0.90
Tearing at Onset of Action (15 Minutes Post-Dose) 20 minutes post-CAC	0.5 units on a scale Standard Deviation 0.65	1.0 units on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.

Outcome measures

Measure	AC-170 0.24% n=50 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=48 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-Dose) 7 minutes post-CAC	0.6 units on a scale Standard Deviation 0.85	1.1 units on a scale Standard Deviation 0.88
Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-Dose) 15 minutes post-CAC	0.8 units on a scale Standard Deviation 0.89	1.3 units on a scale Standard Deviation 1.00
Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-Dose) 20 minutes post-CAC	1.0 units on a scale Standard Deviation 1.01	1.3 units on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 15 minutes after drop instillation. Rhinorrhea was assessed by the patient on a 0-4 scale (0=none to 4=severe). Rhinorrhea score for each time point was analyzed.

Outcome measures

Measure	AC-170 0.24% n=43 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=44 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Rhinorrhea at Onset of Action (15 Minutes Post-Dose) 20 minutes post-CAC	0.8 units on a scale Standard Deviation 0.78	1.1 units on a scale Standard Deviation 1.05
Rhinorrhea at Onset of Action (15 Minutes Post-Dose) 7 minutes post-CAC	0.5 units on a scale Standard Deviation 0.70	1.3 units on a scale Standard Deviation 1.05
Rhinorrhea at Onset of Action (15 Minutes Post-Dose) 15 minutes post-CAC	0.7 units on a scale Standard Deviation 0.89	1.3 units on a scale Standard Deviation 1.12

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.

Outcome measures

Measure	AC-170 0.24% n=50 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=48 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose) 7 minutes post-CAC	0.5 units on a scale Standard Deviation 0.79	0.9 units on a scale Standard Deviation 0.99
Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose) 15 minutes post-CAC	1.0 units on a scale Standard Deviation 1.01	1.0 units on a scale Standard Deviation 1.11
Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose) 20 minutes post-CAC	0.9 units on a scale Standard Deviation 1.00	0.9 units on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Pruritus was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Pruritus score for each time point was analyzed.

Outcome measures

Measure	AC-170 0.24% n=43 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=44 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Nasal Pruritus at Onset of Action (15 Minutes Post-Dose) 7 minutes post-CAC	0.4 units on a scale Standard Deviation 0.76	0.8 units on a scale Standard Deviation 0.87
Nasal Pruritus at Onset of Action (15 Minutes Post-Dose) 15 minutes post-CAC	0.6 units on a scale Standard Deviation 1.05	0.8 units on a scale Standard Deviation 0.99
Nasal Pruritus at Onset of Action (15 Minutes Post-Dose) 20 minutes post-CAC	0.6 units on a scale Standard Deviation 0.87	0.9 units on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.

Outcome measures

Measure	AC-170 0.24% n=50 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=48 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose) 7 minutes post-CAC	0.4 units on a scale Standard Deviation 0.73	1.2 units on a scale Standard Deviation 1.10
Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose) 15 minutes post-CAC	0.8 units on a scale Standard Deviation 1.00	1.5 units on a scale Standard Deviation 1.25
Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose) 20 minutes post-CAC	1.0 units on a scale Standard Deviation 1.14	1.6 units on a scale Standard Deviation 1.27

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 15 minutes after drop instillation. Ear or Palate Pruritus was assessed by the patient on a single 0-4 scale (0=none to 4=severe). Ear or Palate Pruritus score for each time point was analyzed.

Outcome measures

Measure	AC-170 0.24% n=43 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=44 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-Dose) 15 minutes post-CAC	0.6 units on a scale Standard Deviation 1.05	1.3 units on a scale Standard Deviation 1.17
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-Dose) 7 minutes post-CAC	0.3 units on a scale Standard Deviation 0.74	0.8 units on a scale Standard Deviation 0.96
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-Dose) 20 minutes post-CAC	0.7 units on a scale Standard Deviation 1.06	1.3 units on a scale Standard Deviation 1.24

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.

Outcome measures

Measure	AC-170 0.24% n=50 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=48 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-Dose) 7 minutes post-CAC	0.5 units on a scale Standard Deviation 0.68	1.0 units on a scale Standard Deviation 0.89
Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-Dose) 15 minutes post-CAC	0.8 units on a scale Standard Deviation 0.85	1.4 units on a scale Standard Deviation 1.08
Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-Dose) 20 minutes post-CAC	1.1 units on a scale Standard Deviation 1.08	1.3 units on a scale Standard Deviation 1.00

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 15 minutes after drop instillation. Nasal Congestion was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Congestion score for each time point was analyzed.

Outcome measures

Measure	AC-170 0.24% n=43 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=44 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Nasal Congestion at Onset of Action (15 Minutes Post-Dose) 15 minutes post-CAC	0.5 units on a scale Standard Deviation 0.86	1.3 units on a scale Standard Deviation 1.17
Nasal Congestion at Onset of Action (15 Minutes Post-Dose) 7 minutes post-CAC	0.4 units on a scale Standard Deviation 0.73	1.1 units on a scale Standard Deviation 1.13
Nasal Congestion at Onset of Action (15 Minutes Post-Dose) 20 minutes post-CAC	0.6 units on a scale Standard Deviation 0.85	1.3 units on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 8 hours + 30 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.

Outcome measures

Measure	AC-170 0.24% n=50 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=48 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Percentage of Participants With At Least One Nasal Symptom at Duration of Action (8 Hours + 30 Minutes Post-Dose) 7 minutes post-CAC	58 % of participants	87.5 % of participants
Percentage of Participants With At Least One Nasal Symptom at Duration of Action (8 Hours + 30 Minutes Post-Dose) 15 minutes post-CAC	78 % of participants	89.6 % of participants
Percentage of Participants With At Least One Nasal Symptom at Duration of Action (8 Hours + 30 Minutes Post-Dose) 20 minutes post-CAC	84 % of participants	89.6 % of participants

SECONDARY outcome

Timeframe: 7, 15, 20 minutes post-CAC

Population: Intent to Treat (ITT). Number of analyzed subjects differ due to subject discontinuation during the study.

A treatment efficacy CAC was performed 15 minutes after drop instillation. For Nasal Composite Score the Total Composite Score ranges from 0 to 16, higher scores represent greater severity. Patients needed to have at least one of the nasal symptoms present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) each symptom was assessed by the patient on a 0-4 scale (0=none to 4=severe). Nasal Composite score for each time point was analyzed.

Outcome measures

Measure	AC-170 0.24% n=43 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=44 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Percentage of Participants With At Least One Nasal Symptom at Onset of Action (15 Minutes Post-Dose) 7 minutes post-CAC	51.2 % of participants	81.8 % of participants
Percentage of Participants With At Least One Nasal Symptom at Onset of Action (15 Minutes Post-Dose) 15 minutes post-CAC	58.1 % of participants	86.4 % of participants
Percentage of Participants With At Least One Nasal Symptom at Onset of Action (15 Minutes Post-Dose) 20 minutes post-CAC	72.1 % of participants	88.6 % of participants

SECONDARY outcome

Timeframe: upon instillation, 1 minute and 2 minutes post instillation

Population: Intent to Treat (ITT)

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.

Outcome measures

Measure	AC-170 0.24% n=51 Participants AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=50 Participants AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Tolerability of Study Medication at Visit 3A 1 minute post-instillation	3.0 units on a scale Standard Deviation 2.33	1.1 units on a scale Standard Deviation 1.14
Tolerability of Study Medication at Visit 3A 2 minutes post-instillation	2.6 units on a scale Standard Deviation 2.14	1.1 units on a scale Standard Deviation 1.13
Tolerability of Study Medication at Visit 3A Upon instillation	1.6 units on a scale Standard Deviation 2.02	0.8 units on a scale Standard Deviation 1.22

Adverse Events

AC-170 0.24%

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

AC-170 0%

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	AC-170 0.24% n=51 participants at risk AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	AC-170 0% n=50 participants at risk AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period
Eye disorders Visual acuity reduced	2.0% 1/51 • Number of events 1 • Adverse events were collected through study completion, an average of 5 weeks.. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	2.0% 1/50 • Number of events 1 • Adverse events were collected through study completion, an average of 5 weeks.. 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 Epistaxis	0.00% 0/51 • Adverse events were collected through study completion, an average of 5 weeks.. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	2.0% 1/50 • Number of events 1 • Adverse events were collected through study completion, an average of 5 weeks.. 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 Rhinitis allergic	0.00% 0/51 • Adverse events were collected through study completion, an average of 5 weeks.. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	2.0% 1/50 • Number of events 1 • Adverse events were collected through study completion, an average of 5 weeks.. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Skin and subcutaneous tissue disorders Dermatitis contact	2.0% 1/51 • Number of events 2 • Adverse events were collected through study completion, an average of 5 weeks.. 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% 0/50 • Adverse events were collected through study completion, an average of 5 weeks.. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/51 • Adverse events were collected through study completion, an average of 5 weeks.. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	2.0% 1/50 • Number of events 1 • Adverse events were collected through study completion, an average of 5 weeks.. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Musculoskeletal and connective tissue disorders Neck pain	2.0% 1/51 • Number of events 1 • Adverse events were collected through study completion, an average of 5 weeks.. 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% 0/50 • Adverse events were collected through study completion, an average of 5 weeks.. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.
Vascular disorders Varicose vein	0.00% 0/51 • Adverse events were collected through study completion, an average of 5 weeks.. All subjects who received study medication were evaluable for the safety analysis. Throughout the visits, staff collected all Adverse Events reported, elicited, or observed.	2.0% 1/50 • Number of events 1 • Adverse events were collected through study completion, an average of 5 weeks.. 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: bergamini@nicox.com

Results disclosure agreements

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