Phase 2
Completed N=236
Safety, Efficacy, Tolerability and Pharmacokinetics of AGN-223575 Ophthalmic Suspension in Patients With Dry Eye Disease
Dry Eye Syndromes
Source: ClinicalTrials.gov NCT02435914 ↗
Enrolled (actual)
236
Serious AEs
1.3%
Results posted
Apr 2019
Primary outcomePrimary: Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale — 1.9; 2.2; 2.0; 2.1 score on a scale
Summary
This study will evaluate the safety, efficacy, tolerability, and systemic pharmacokinetics of 3 different doses of topical ophthalmic AGN-223575 suspension compared to AGN-223575 vehicle in patients with dry eye disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Conjunctival Redness Score in the Study Eye Using a 5-Point Scale |
1.9; 2.2; 2.0; 2.1; -0.7; -0.9 | — |
| SECONDARY Change From Baseline in Ocular Surface Disease Index (OSDI) Total Score Using a 5-Point Scale |
49.65; 51.00; 48.95; 52.63; -14.64; -15.92 | — |
| SECONDARY Change From Baseline in Corneal Staining Score of the Study Eye Using a 6-Point Scale |
1.7; 1.9; 1.8; 1.8; -0.6; -0.6 | — |
| SECONDARY Percentage of Participants With Complete Redness Response (Yes/No) in the Study Eye |
10.7; 12.1; 15.0; 10.5; 89.3; 87.9 | — |
Eligibility Criteria
Inclusion Criteria
- Signs and symptoms of dry eye disease
- Has used RESTASIS and/or artificial tears in both eyes twice a day for at least 60 days.
Exclusion Criteria
- History of glaucoma, or ocular hypertension
- Diagnosis of ocular infection
- Use of contact lenses in the past 14 days or expected use during the study
- Use of any topical ophthalmic medications in the past 30 days
- Use of corticosteroids in the past 30 days.
Data sourced from ClinicalTrials.gov (NCT02435914). 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.