Phase 3
Completed N=100
A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle
Source: ClinicalTrials.gov NCT01685242 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-dose) — 1.76; 2.69; 1.85; 2.74 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 This can indicate results are unpublished — a known publication-bias signal.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 (8 Hours + 30 Minutes Post-dose) |
1.76; 2.69; 1.85; 2.74; 1.54; 2.53 | — |
| PRIMARY Ocular Itching at Onset of Action (15 Minutes Post-dose) |
1.00; 2.38; 1.18; 2.43; 1.11; 2.11 | — |
| PRIMARY Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-dose) |
1.97; 2.27; 2.30; 2.34; 2.30; 2.32 | — |
| PRIMARY Conjunctival Redness at Onset of Action (15 Minutes Post-dose) |
1.66; 1.98; 1.93; 2.09; 1.95; 2.09 | — |
| SECONDARY Ciliary Redness at Duration of Action (8 Hours + 30 Minutes) |
1.84; 2.19; 2.18; 2.33; 2.21; 2.30 | — |
| SECONDARY Ciliary Redness at Onset of Action (15 Minutes Post-dose) |
1.57; 1.98; 1.86; 2.06; 1.90; 2.05 | — |
| SECONDARY Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-dose) |
1.97; 2.31; 2.28; 2.35; 2.30; 2.35 | — |
| SECONDARY Episcleral Redness at Onset of Action (15 Minutes Post-dose) |
1.77; 2.03; 2.03; 2.13; 2.02; 2.11 | — |
| SECONDARY Chemosis at Duration of Action (8 Hours + 30 Minutes Post-dose) |
0.89; 1.24; 1.29; 1.44; 1.32; 1.51 | — |
| SECONDARY Chemosis at Onset of Action (15 Minutes) |
0.63; 1.03; 0.99; 1.28; 1.14; 1.43 | — |
| SECONDARY Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-dose) |
0.6; 1.1; 0.8; 1.2; 0.8; 1.1 | — |
| SECONDARY Eyelid Swelling at Onset of Action (15 Minutes Post-dose) |
0.6; 1.0; 0.8; 1.0; 0.8; 1.0 | — |
| SECONDARY Tearing at Duration of Action (8 Hours + 30 Minutes Post-dose) |
0.8; 1.0; 0.9; 1.0; 1.0; 0.9 | — |
| SECONDARY Tearing at Onset of Action (15 Minutes Post-dose) |
0.6; 1.0; 0.8; 0.9; 0.7; 0.8 | — |
| SECONDARY Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-dose) |
0.5; 1.3; 0.8; 1.6; 0.7; 1.5 | — |
| SECONDARY Rhinorrhea at Onset of Action (15 Minutes Post-dose) |
0.5; 1.1; 0.9; 1.3; 0.8; 1.2 | — |
| SECONDARY Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose) |
0.3; 0.8; 0.5; 1.0; 0.5; 0.9 | — |
| SECONDARY Nasal Pruritus at Onset of Action (15 Minutes Post-dose) |
0.4; 0.6; 0.6; 0.8; 0.6; 0.7 | — |
| SECONDARY Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-dose) |
0.5; 0.8; 0.9; 1.3; 1.0; 1.3 | — |
| SECONDARY Ear or Palate Pruritus at Onset of Action (15 Minutes Post-dose) |
0.3; 0.8; 0.7; 1.1; 0.9; 1.1 | — |
| SECONDARY Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-dose) |
0.7; 1.2; 0.9; 1.6; 1.0; 1.5 | — |
| SECONDARY Nasal Congestion at Onset of Action (15 Minutes Post-dose) |
0.8; 1.1; 1.1; 1.3; 1.1; 1.4 | — |
| SECONDARY Nasal Composite Score at Duration of Action (8 Hours + 30 Minutes Post-dose) |
61.2; 82; 81.6; 94; 83.7; 94 | — |
| SECONDARY Nasal Composite Score at Onset of Action (15 Minutes Post-dose) |
65.3; 83; 81.6; 91.5; 77.6; 93.6 | — |
| SECONDARY Tolerability of Study Medication at Visit 3A |
1.2; 1.0; 1.4; 1.2; 1.3; 1.0 | — |
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 trial parameters
- use of disallowed medication during the period indicated prior to the enrollment or during the study
Data sourced from ClinicalTrials.gov (NCT01685242). 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.