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

A Single-Center, Double-Masked, Randomization, Vehicle-Controlled, Evaluation of the Onset and Duration of Action of AC-170 0.24% Ophthalmic Solution (Formula AFH-002) Compared to Vehicle (Formula AFH-001) in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01685242

Enrollment

100

Registered

2012-09-14

Start date

2012-09-30

Completion date

2012-11-30

Last updated

2017-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Conjunctivitis

Brief summary

The purpose of this study is to evaluate the onset and duration of action of AC-170 0.24% compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (CAC) model.

Interventions

DRUGAC-170 0.24%

1 drop in each eye at 2 separate times during a 14 day period

DRUGAC-170 0%

1 drop in each eye at 2 separate times during a 14 day period

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Inclusion criteria

* positive bilateral conjunctival allergen challenge (CAC)reaction

Exclusion criteria

* known contraindications or sensitivities to the study medication or its components * any ocular condition that, in the opinion of the investigator, could affect the subjects safety trial parameters * use of disallowed medication during the period indicated prior to the enrollment or during the study

Design outcomes

Primary

Measure	Time frame	Description
Ocular Itching at Onset of Action (15 Minutes Post-dose)	3, 5, 7 minutes post-CAC	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.
Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-dose)	3, 5, 7 minutes post-CAC	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.
Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Conjunctival Redness at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.

Secondary

Measure	Time frame	Description
Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Chemosis at Onset of Action (15 Minutes)	7, 15, 20 minutes post-CAC	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.
Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Eyelid Swelling at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Tearing at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Rhinorrhea at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Ciliary Redness at Duration of Action (8 Hours + 30 Minutes)	7, 15, 20 minutes post-CAC	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.
Nasal Pruritus at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Nasal Congestion at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Nasal Composite Score at Duration of Action (8 Hours + 30 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Nasal Composite Score at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Tolerability of Study Medication at Visit 3A	upon instillation, 1 minute and 2 minutes post instillation	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.
Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Ciliary Redness at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.
Episcleral Redness at Onset of Action (15 Minutes Post-dose)	7, 15, 20 minutes post-CAC	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.

Countries

United States

Participant flow

Recruitment details

Subjects were recruited from one site in the US.

Pre-assignment details

There were 100 subjects enrolled, 4 subjects discontinued, and 96 subjects completed the study. Participant flow and baseline characteristics are presented for the 100 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%.

Participants by arm

Arm	Count
AC-170 0.24% AC-170 0.24%: 1 drop in each eye at 2 separate times during a 14 day period	50
AC-170 0% AC-170 0%: 1 drop in each eye at 2 separate times during a 14 day period	50
Total	100

Baseline characteristics

Characteristic	AC-170 0.24%	Total	AC-170 0%
Age, Continuous	39.5 years STANDARD_DEVIATION 17.32	38.8 years STANDARD_DEVIATION 15.93	38.1 years STANDARD_DEVIATION 14.56
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants	15 Participants	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants	85 Participants	46 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	3 Participants	2 Participants
Race (NIH/OMB) Black or African American	3 Participants	5 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	44 Participants	90 Participants	46 Participants
Region of Enrollment United States	50 participants	100 participants	50 participants
Sex: Female, Male Female	37 Participants	67 Participants	30 Participants
Sex: Female, Male Male	13 Participants	33 Participants	20 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	5 / 50	5 / 50
serious Total, serious adverse events	0 / 50	0 / 50

Outcome results

Primary

Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose)

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.

Time frame: 7, 15, 20 minutes post-CAC