Phase 3
Completed N=101
A Multi-Center, Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle
Source: ClinicalTrials.gov NCT01881113 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcomePrimary: Ocular Itching at Duration of Action (8 Hours + 30 Minutes Post-Dose) — 1.94; 2.86; 2.03; 2.94 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 This can indicate results are unpublished — a known publication-bias signal.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) |
1.94; 2.86; 2.03; 2.94; 1.82; 2.66 | — |
| PRIMARY Ocular Itching at Onset of Action (15 Minutes Post-Dose) |
1.01; 2.54; 1.17; 2.51; 1.15; 2.23 | — |
| PRIMARY Conjunctival Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose) |
1.97; 2.39; 2.13; 2.38; 2.09; 2.40 | — |
| PRIMARY Conjunctival Redness at Onset of Action (15 Minutes Post-Dose) |
1.92; 2.38; 2.19; 2.37; 2.15; 2.41 | — |
| SECONDARY Ciliary Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose) |
1.71; 2.15; 1.93; 2.05; 1.87; 2.19 | — |
| SECONDARY Ciliary Redness at Onset of Action (15 Minutes Post-Dose) |
1.62; 2.29; 2.05; 2.34; 2.09; 2.36 | — |
| SECONDARY Episcleral Redness at Duration of Action (8 Hours + 30 Minutes Post-Dose) |
1.92; 2.29; 2.08; 2.27; 2.06; 2.30 | — |
| SECONDARY Episcleral Redness at Onset of Action (15 Minutes Post-Dose) |
1.91; 2.31; 2.22; 2.32; 2.18; 2.36 | — |
| SECONDARY Chemosis at Duration of Action (8 Hours + 30 Minutes Post-Dose) |
0.63; 0.96; 0.89; 1.28; 0.95; 1.27 | — |
| SECONDARY Chemosis at Onset of Action (15 Minutes Post-Dose) |
0.35; 0.58; 0.59; 0.75; 0.67; 0.85 | — |
| SECONDARY Eyelid Swelling at Duration of Action (8 Hours + 30 Minutes Post-Dose) |
0.7; 1.4; 0.8; 1.4; 0.9; 1.4 | — |
| SECONDARY Eyelid Swelling at Onset of Action (15 Minutes Post-Dose) |
0.4; 1.2; 0.5; 1.3; 0.4; 1.2 | — |
| SECONDARY Tearing at Duration of Action (8 Hours + 30 Minutes Post-Dose) |
0.8; 1.2; 0.8; 1.2; 0.9; 1.0 | — |
| SECONDARY Tearing at Onset of Action (15 Minutes Post-Dose) |
0.5; 1.1; 0.5; 1.1; 0.5; 1.0 | — |
| SECONDARY Rhinorrhea at Duration of Action (8 Hours + 30 Minutes Post-Dose) |
0.6; 1.1; 0.8; 1.3; 1.0; 1.3 | — |
| SECONDARY Rhinorrhea at Onset of Action (15 Minutes Post-Dose) |
0.5; 1.3; 0.7; 1.3; 0.8; 1.1 | — |
| SECONDARY Nasal Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose) |
0.5; 0.9; 1.0; 1.0; 0.9; 0.9 | — |
| SECONDARY Nasal Pruritus at Onset of Action (15 Minutes Post-Dose) |
0.4; 0.8; 0.6; 0.8; 0.6; 0.9 | — |
| SECONDARY Ear or Palate Pruritus at Duration of Action (8 Hours + 30 Minutes Post-Dose) |
0.4; 1.2; 0.8; 1.5; 1.0; 1.6 | — |
| SECONDARY Ear or Palate Pruritus at Onset of Action (15 Minutes Post-Dose) |
0.3; 0.8; 0.6; 1.3; 0.7; 1.3 | — |
| SECONDARY Nasal Congestion at Duration of Action (8 Hours + 30 Minutes Post-Dose) |
0.5; 1.0; 0.8; 1.4; 1.1; 1.3 | — |
| SECONDARY Nasal Congestion at Onset of Action (15 Minutes Post-Dose) |
0.4; 1.1; 0.5; 1.3; 0.6; 1.3 | — |
| SECONDARY Percentage of Participants With At Least One Nasal Symptom at Duration of Action (8 Hours + 30 Minutes Post-Dose) |
58; 87.5; 78; 89.6; 84; 89.6 | — |
| SECONDARY Percentage of Participants With At Least One Nasal Symptom at Onset of Action (15 Minutes Post-Dose) |
51.2; 81.8; 58.1; 86.4; 72.1; 88.6 | — |
| SECONDARY Tolerability of Study Medication at Visit 3A |
1.6; 0.8; 3.0; 1.1; 2.6; 1.1 | — |
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 (NCT01881113). 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.