Phase 2
Completed N=72
The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients
Source: ClinicalTrials.gov NCT01250171 ↗Enrolled (actual)
72
Serious AEs
1.4%
Results posted
Jan 2013
Primary outcomePrimary: Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4 — 0.23; 0.12; 0.26 Units on a scale
Summary
This study assessed the effects of a single intravenous dose of secukinumab (AIN457) 10 mg/kg or canakinumab (ACZ885) 10 mg/kg on the signs and symptoms of dry eye. In addition, the pharmacokinetic, pharmacodynamic, and safety profiles of secukinumab and canakinumab were assessed. Blood samples were collected for the analysis of the effect of secukinumab and canakinumab on select biomarkers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4 |
0.23; 0.12; 0.26 | — |
| SECONDARY Change From Baseline on the Ora Corneal Staining Scale at Weeks 1, 4, and 8 |
0.3; 0.2; 0.4; 0.4; 0.2; 0.4 | — |
| SECONDARY Change From Baseline on the Schirmer Test at Weeks 1, 4, and 8 |
-0.5; 0.1; 0.3; -0.1; 0.0; 0.1 | — |
| SECONDARY Change From Baseline in Tear Film Breakup Time at Weeks 1, 4, and 8 |
0.29; 0.21; 0.26; 0.74; -0.16; 0.52 | — |
| SECONDARY Change From Baseline on the Conjunctival Redness Scale (Ora) at Weeks 1, 4, and 8 |
0.19; 0.10; 0.31; 0.15; -0.07; 0.31 | — |
| SECONDARY Change From Baseline in the Ocular Surface Disease Index (OSDI) at Weeks 1, 4, and 8 |
5.6; 8.7; 5.5; 4.8; 9.9; 4.6 | — |
| SECONDARY Desire for Artificial Tear Use at Day 1 and Weeks 1, 4, and 8 |
46; 50; 57; 18; 15; 9 | — |
| SECONDARY Change From Baseline in Best Corrected Visual Acuity at Weeks 1, 4, and 8 |
0.5; 0.3; 0.9; 0.1; 1.2; -0.1 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients age 18-85 with a diagnosis of moderate to severe dry eye.
- Schirmer test without anesthesia ≥ 1 and < 10 mm wetting over 5 minutes in at least 1 eye.
- Tear break up time < 7 seconds in at least 1 eye.
- Corneal staining score ≥ 3 (National Eye Institute [NEI] grading scale).
- Conjunctival redness of ≥ 1.
- Ocular surface disease index of modest to severe.
- Ability to provide informed consent.
Exclusion Criteria
- Pregnant or breastfeeding women.
- Hemoglobin < 10 g/dl.
- Total white blood count (WBC) outside the range of 3000-14,000/µl.
- Platelets < 100,000/µl.
- Use of ocular, periocular, or systemic steroids within 60 days prior to screening.
- Use of contact lenses or prior corneal refractive surgery in either eye.
- Requirement of eye drop use during the study.
- Anesthetic or neurotrophic corneas.
- Temporary punctal plugs.
- Recent or planned exposure to live vaccinations.
- Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01250171). 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.