Phase 2 N=83 Randomized Double-blind Treatment

Efficacy of AC-150 for the Treatment of Allergic Conjunctivitis in the Enviro-CAC™ Model

Allergic Conjunctivitis

Bottom Line

View on ClinicalTrials.gov: NCT01134328 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2017

Primary outcome: Primary: Ocular Itching at Onset of Action (15 Minutes Post-dose) — 1.33; 0.99; 2.11; 2.90 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AC-150 Combo (Drug); AC-150A 0.1% (Drug); AC-150B 0.005% (Drug); Vehicle (Drug)
Age: Pediatric, Adult, Older Adult · 10+ yrs
Sex: All
Sponsor: Aciex Therapeutics, Inc.
Primary completion: Jul 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Ocular Itching at Onset of Action (15 Minutes Post-dose)	1.33; 0.99; 2.11; 2.90; 1.44; 1.33	—
PRIMARY Ocular Itching at Duration of Action (16 Hours Post-dose)	1.75; 1.92; 1.88; 3.04; 1.95; 2.24	—
PRIMARY Ocular Itching at 8 Hours Post-dose at Visit 4A	1.43; 1.53; 2.01; 2.99; 1.56; 1.83	—
PRIMARY Conjunctival Redness at Onset of Action (15 Minutes Post-dose)	1.70; 1.97; 2.18; 2.49; 2.04; 2.25	—
PRIMARY Conjunctival Redness at Duration of Action (16 Hours Post-dose)	1.56; 1.78; 1.83; 2.01; 1.68; 1.84	—
PRIMARY Conjunctival Redness at 8 Hours Post-dose at Visit 4A	1.39; 1.66; 1.81; 1.96; 1.39; 1.70	—
SECONDARY Ciliary Redness at Onset of Action (15 Minutes Post-dose)	1.44; 1.84; 2.35; 2.37; 1.89; 2.25	—
SECONDARY Ciliary Redness at Duration of Action (16 Hours Post-dose)	1.38; 1.81; 1.71; 2.03; 1.51; 1.90	—
SECONDARY Ciliary Redness at 8 Hours Post-dose at Visit 4A	1.04; 1.65; 1.68; 2.01; 1.08; 1.69	—
SECONDARY Episcleral Redness at Onset of Action (15 Minutes Post-dose)	1.63; 2.03; 2.35; 2.50; 1.90; 2.40	—
SECONDARY Episcleral Redness at Duration of Action (16 Hours Post-dose)	1.72; 2.12; 2.15; 2.37; 1.79; 2.24	—
SECONDARY Episcleral Redness at 8 Hours Post-dose at Visit 4A	1.49; 1.88; 2.04; 2.34; 1.50; 2.04	—
SECONDARY Total Redness at Onset of Action (15 Minutes Post-dose)	4.72; 5.96; 6.99; 7.37; 5.76; 7.03	—
SECONDARY Total Redness at Duration of Action (16 Hours Post-dose)	4.60; 5.75; 5.66; 6.40; 4.92; 6.03	—
SECONDARY Total Redness at 8 Hours Post-Dose at Visit 4A	3.83; 5.25; 5.50; 6.29; 3.88; 5.50	—
SECONDARY Lid Swelling at Onset of Action (15 Minutes Post-dose)	0.2; 0.5; 1.2; 1.4; 0.4; 0.7	—
SECONDARY Lid Swelling Duration of Action (16 Hours Post-dose)	0.6; 1.2; 1.1; 1.5; 0.7; 1.3	—
SECONDARY Lid Swelling at 8 Hours Post-dose at Visit 4A	0.4; 0.7; 1.1; 1.6; 0.5; 1.0	—
SECONDARY Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose)	0.4; 0.3; 0.5; 1.2; 0.4; 0.6	—
SECONDARY Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose)	0.4; 0.4; 0.4; 1.5; 0.7; 1.3	—
SECONDARY Ear or Palate Pruritus at 8 Hours Post-dose at Visit 4A	0.3; 0.7; 0.6; 1.2; 0.4; 1.1	—
SECONDARY Tolerability of Study Medication at Visit 2B	2.3; 2.2; 1.1; 2.0; 2.3; 2.0	—
SECONDARY Tolerability of Study Medication at Visit 3	2.0; 1.5; 0.9; 1.4; 1.6; 1.4	—

Summary

The purpose of this study is to evaluate the efficacy of AC-150 compared to vehicle and its components in the prevention of the signs and symptoms of allergic conjunctivitis in Enviro-CAC™ Model.

Eligibility Criteria

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 or trial parameters.
Use of disallowed medications during the period indicated prior to study enrollment or during the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01134328). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.