Status:
COMPLETED
The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Dry Eye
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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, p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01250171
Start Date
November 1 2010
End Date
September 1 2011
Last Update
January 7 2013
Active Locations (1)
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1
Ora Inc, 300 Brickstone Square,
Andover, Massachusetts, United States, 01810