Phase 3
Completed N=512
A Multi-Center Study Evaluating the Safety of AC-170 0.24%
Atopic Disease (Including Allergic Conjunctivitis)
Source: ClinicalTrials.gov NCT02132169 ↗
Enrolled (actual)
512
Serious AEs
0.4%
Results posted
Jul 2017
Primary outcomePrimary: Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) — 0.9; 0.5; 0.7; 0.3 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 This can indicate results are unpublished — a known publication-bias signal.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 safety of AC-170 0.24% used twice daily in Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic disease (including allergic conjunctivitis).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) |
0.9; 0.5; 0.7; 0.3; 0.6; 0.3 | — |
| PRIMARY Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8) |
0.8; 0.3; 0.5; 0.3; 0.4; 0.2 | — |
| PRIMARY Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22) |
0.6; 0.2; 0.4; 0.2; 0.3; 0.1 | — |
| SECONDARY Safety of AC 170 0.024% Compared to Its Vehicle |
70; 40 | — |
Eligibility Criteria
Inclusion Criteria
- at least 2 years of age
- be able to self-administer eye drops or have a parent/legal guardian available for this purpose
- if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis)
- have ocular health within normal limits
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 (NCT02132169). 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.