Phase 3
N=101
Efficacy of AC-170 for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (CAC) Model
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01332188 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Ocular Itching at Duration of Action (16 Hours Post-dose) — 1.91; 2.00; 1.65; 2.48 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- AC-170 0.05% (Drug); AC-170 0.1% (Drug); AC-170 0.24% (Drug); AC-170 0% (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Aciex Therapeutics, Inc.
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching at Duration of Action (16 Hours Post-dose) |
1.91; 2.00; 1.65; 2.48; 2.01; 2.04 | — |
| PRIMARY Ocular Itching at Duration of Action (24 Hours Post-dose) |
1.99; 1.78; 1.90; 2.24; 2.00; 1.92 | — |
| PRIMARY Ocular Itching at Onset of Action (15 Minutes Post-dose) |
1.05; 0.84; 0.91; 1.94; 1.19; 1.09 | — |
| PRIMARY Conjunctival Redness at Duration of Action (16 Hours Post-dose) |
1.62; 1.59; 1.45; 1.79; 1.68; 1.65 | — |
| PRIMARY Conjunctival Redness at Duration of Action (24 Hours Post-dose) |
1.43; 1.38; 1.71; 1.70; 1.63; 1.59 | — |
| PRIMARY Conjunctival Redness at Onset of Action (15 Minutes Post-dose) |
1.44; 1.45; 1.66; 1.88; 1.81; 1.67 | — |
| SECONDARY Ciliary Redness at Duration of Action (16 Hours Post-dose) |
1.47; 1.53; 1.34; 1.81; 1.60; 1.65 | — |
| SECONDARY Ciliary Redness at Duration of Action (24 Hours Post-dose) |
1.36; 1.22; 1.50; 1.55; 1.49; 1.47 | — |
| SECONDARY Ciliary Redness at Onset of Action (15 Minutes Post-dose) |
1.24; 1.24; 1.27; 1.67; 1.59; 1.51 | — |
| SECONDARY Episcleral Redness at Duration of Action (16 Hours Post-dose) |
1.68; 1.74; 1.57; 1.90; 1.81; 1.77 | — |
| SECONDARY Episcleral Redness at Duration of Action (24 Hours Post-dose) |
1.53; 1.37; 1.73; 1.80; 1.72; 1.63 | — |
| SECONDARY Episcleral Redness at Onset of Action (15 Minutes Post-dose) |
1.52; 1.49; 1.64; 1.93; 1.86; 1.73 | — |
| SECONDARY Chemosis at Duration of Action (16 Hours Post-dose) |
0.71; 0.58; 0.53; 0.72; 0.93; 0.70 | — |
| SECONDARY Chemosis at Duration of Action (24 Hours Post-dose) |
0.68; 0.52; 0.55; 0.68; 0.87; 0.64 | — |
| SECONDARY Chemosis at Onset of Action (15 Minutes Post-dose) |
0.49; 0.43; 0.54; 0.74; 0.74; 0.52 | — |
| SECONDARY Eyelid Swelling at Duration of Action (16 Hours Post-dose) |
0.6; 0.8; 0.8; 0.9; 0.7; 0.9 | — |
| SECONDARY Eyelid Swelling at Duration of Action (24 Hours Post-dose) |
0.7; 0.7; 0.9; 0.7; 0.8; 0.8 | — |
| SECONDARY Eyelid Swelling at Onset of Action (15 Minutes Post-dose) |
0.4; 0.5; 0.5; 0.7; 0.5; 0.6 | — |
| SECONDARY Tearing at Duration of Action (16 Hours Post-dose) |
1.0; 0.8; 0.6; 0.6; 0.8; 0.5 | — |
| SECONDARY Tearing at Duration of Action (24 Hours Post-dose) |
1.0; 0.7; 0.6; 0.8; 1.1; 0.6 | — |
| SECONDARY Tearing at Onset of Action (15 Minutes Post-dose) |
0.7; 0.5; 0.3; 0.6; 0.5; 0.5 | — |
| SECONDARY Rhinorrhea at Duration of Action (16 Hours Post-dose) |
1.1; 0.4; 0.7; 0.7; 1.2; 0.6 | — |
| SECONDARY Rhinorrhea at Duration of Action (24 Hours Post-dose) |
1.1; 0.6; 0.8; 0.7; 1.1; 0.7 | — |
| SECONDARY Rhinorrhea at Onset of Action (15 Minutes Post-dose) |
0.6; 0.2; 0.3; 0.6; 0.9; 0.4 | — |
| SECONDARY Nasal Pruritus at Duration of Action (16 Hours Post-dose) |
0.6; 0.2; 0.5; 0.4; 0.6; 0.4 | — |
| SECONDARY Nasal Pruritus at Duration of Action (24 Hours Post-dose) |
0.7; 0.4; 0.4; 0.4; 0.7; 0.4 | — |
| SECONDARY Nasal Pruritus at Onset of Action (15 Minutes Post-dose) |
0.4; 0.2; 0.3; 0.4; 0.4; 0.3 | — |
| SECONDARY Ear or Palate Pruritus at Duration of Action (16 Hours Post-dose) |
0.4; 0.4; 0.3; 0.5; 0.9; 0.8 | — |
| SECONDARY Ear or Palate Pruritus at Duration of Action (24 Hours Post-dose) |
0.6; 0.3; 0.4; 0.5; 0.7; 0.6 | — |
| SECONDARY Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) |
0.6; 0.2; 0.3; 0.4; 08; 0.4 | — |
| SECONDARY Nasal Congestion at Onset of Action (16 Hours Post-dose) |
1.2; 0.5; 0.8; 0.8; 1.4; 0.6 | — |
| SECONDARY Nasal Congestion at Duration of Action (24 Hours Post-dose) |
0.9; 0.6; 0.8; 0.7; 1.2; 0.6 | — |
| SECONDARY Nasal Congestion at Onset of Action (15 Minutes Post-dose) |
0.7; 0.4; 0.4; 0.8; 1.1; 0.5 | — |
| SECONDARY Nasal Composite Score at Duration of Action (16 Hours Post-dose) |
82.6; 66.7; 52.4; 76.0; 82.6; 79.2 | — |
| SECONDARY Nasal Composite Score at Duration of Action (24 Hours Post-dose) |
69.6; 76.0; 85.7; 68.0; 82.6; 84.0 | — |
| SECONDARY Nasal Composite Score at Onset of Action (15 Minutes Post-dose) |
52.2; 56; 47.6; 72; 82.6; 56 | — |
| SECONDARY Tolerability of Study Medication at Visit 3A |
0.5; 0.7; 1.3; 0.6; 0.7; 0.9 | — |
Summary
The purpose of this study is to evaluate the efficacy of different concentrations of AC-170 compared to vehicle in the prevention of the signs and symptoms of allergic conjunctivitis in the conjunctival allergen challenge (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 the study enrollment or during the study.
Data sourced from ClinicalTrials.gov (NCT01332188). 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.