Phase 3
Completed N=91
A Multi-Center Study Evaluating the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC)
Source: ClinicalTrials.gov NCT01551056 ↗Enrolled (actual)
91
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose) — 1.71; 2.34; 1.88; 2.50 units on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching at Duration of Action (16 Hours + 1 Hour Post-dose) |
1.71; 2.34; 1.88; 2.50; 1.76; 2.22 | — |
| PRIMARY Ocular Itching at Onset of Action (15 Minutes Post-dose) |
0.71; 2.18; 1.01; 2.31; 1.00; 2.10 | — |
| PRIMARY Conjunctival Redness at Duration of Action (16 Hours + 1 Hour Post-dose) |
1.72; 1.94; 1.96; 2.02; 1.92; 1.98 | — |
| PRIMARY Conjunctival Redness at Onset of Action (15 Minutes Post-dose) |
2.02; 2.05; 2.23; 2.13; 2.28; 2.18 | — |
| SECONDARY Ciliary Redness at Duration of Action (16 Hours + 1 Hour Post-dose) |
1.54; 1.82; 1.77; 1.96; 1.72; 1.93 | — |
| SECONDARY Ciliary Redness at Onset of Action (15 Minutes Post-dose) |
1.64; 1.90; 1.85; 1.99; 1.95; 2.06 | — |
| SECONDARY Episcleral Redness at Duration of Action (16 Hours + 1 Hour Post-dose) |
1.72; 1.94; 1.94; 2.07; 1.89; 2.03 | — |
| SECONDARY Episcleral Redness at Onset of Action (15 Minutes Post-dose) |
1.88; 1.96; 2.10; 2.10; 2.20; 2.16 | — |
| SECONDARY Chemosis at Duration of Action (16 Hours + 1 Hour Post-dose) |
0.49; 0.70; 0.71; 1.01; 0.76; 1.05 | — |
| SECONDARY Chemosis at Onset of Action (15 Minutes Post-dose) |
0.74; 0.97; 1.12; 1.42; 1.22; 1.53 | — |
| SECONDARY Eyelid Swelling at Duration of Action (16 Hours + 1 Hour Post-dose) |
0.7; 1.1; 1.0; 1.3; 1.0; 1.2 | — |
| SECONDARY Eyelid Swelling at Onset of Action (15 Minutes Post-dose) |
0.6; 0.9; 0.8; 1.1; 0.8; 1.1 | — |
| SECONDARY Tearing at Duration of Action (16 Hours + 1 Hour Post-dose) |
0.8; 1.1; 0.9; 1.2; 0.9; 1.1 | — |
| SECONDARY Tearing at Onset of Action (15 Minutes Post-dose) |
0.4; 1.0; 0.6; 0.8; 0.7; 0.8 | — |
| SECONDARY Rhinorrhea at Duration of Action (16 Hours +1 Hour Post-dose) |
0.7; 1.4; 1.0; 1.3; 1.1; 1.4 | — |
| SECONDARY Rhinorrhea at Onset of Action (15 Minutes Post-dose) |
0.3; 1.1; 0.5; 1.0; 0.6; 1.0 | — |
| SECONDARY Nasal Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) |
0.4; 1.0; 0.8; 1.0; 0.8; 1.1 | — |
| SECONDARY Nasal Pruritis at Onset of Action (15 Minutes Post-dose) |
0.3; 0.7; 0.3; 0.8; 0.5; 0.7 | — |
| SECONDARY Ear or Palate Pruritis at Duration of Action (16 Hours + 1 Hour Post-dose) |
0.4; 1.0; 1.0; 1.3; 1.2; 1.5 | — |
| SECONDARY Ear or Palate Pruritis at Onset of Action (15 Minutes Post-dose) |
0.3; 1.0; 0.5; 1.1; 0.6; 1.0 | — |
| SECONDARY Nasal Congestion at Duration of Action (16 Hours + 1 Hour Post-dose) |
0.9; 1.3; 1.1; 1.5; 1.2; 1.4 | — |
| SECONDARY Nasal Congestion at Onset of Action (15 Minutes Post-dose) |
0.3; 1.0; 0.7; 1.2; 0.8; 1.2 | — |
| SECONDARY Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Duration of Action (16 Hours + 1 Hour Post-dose) |
68.9; 84.4; 80.0; 88.9; 86.7; 93.3 | — |
| SECONDARY Number of Participants With At Least One of the Nasal Symptoms Present (Rhinorrhea + Nasal Pruritus + Ear or Palate Pruritus + Nasal Congestion) at Onset of Action (15 Minutes Post-dose) |
50; 82.2; 65.9; 86.7; 70.5; 84.4 | — |
| SECONDARY Tolerability of Study Medication at Visit 3A |
1.2; 0.9; 2.4; 0.6; 2.1; 0.6 | — |
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 medication during the period indicated prior to the enrollment or during the study
Data sourced from ClinicalTrials.gov (NCT01551056). 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. Informational only — not medical advice.