The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients
Completed · Phase 2 · Has a placebo group
Conditions studied: Dry Eye
In brief
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.
Key facts
- Study ID
- NCT01250171
- Run by
- Novartis Pharmaceuticals
- People needed
- 72
- Starts
- 2010-11-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2013-01-07
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Ora Inc, 300 Brickstone Square, — Andover, Massachusetts, United States
Full record on ClinicalTrials.gov
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