Clinical trial NCT01250171: The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients
Official title: A Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Intravenous Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Keywords: Dry eye
IL17/ IL-1β
Biologic
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-11-30
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, 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.


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.

Primary outcomes:
measure: Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4
timeFrame: Baseline to Week 4
Secondary outcomes:
measure: Change From Baseline on the Ora Corneal Staining Scale at Weeks 1, 4, and 8
timeFrame: Baseline to Weeks 1, 4, and 8
measure: Change From Baseline on the Schirmer Test at Weeks 1, 4, and 8
timeFrame: Baseline to Weeks 1, 4, and 8
measure: Change From Baseline in Tear Film Breakup Time at Weeks 1, 4, and 8
timeFrame: Baseline to Weeks 1, 4, and 8
measure: Change From Baseline on the Conjunctival Redness Scale (Ora) at Weeks 1, 4, and 8
timeFrame: Baseline to Weeks 1, 4, and 8
measure: Change From Baseline in the Ocular Surface Disease Index (OSDI) at Weeks 1, 4, and 8
timeFrame: Baseline to Weeks 1, 4, and 8
measure: Desire for Artificial Tear Use at Day 1 and Weeks 1, 4, and 8
timeFrame: Day 1 and Weeks 1, 4, and 8
measure: Change From Baseline in Best Corrected Visual Acuity at Weeks 1, 4, and 8
timeFrame: Baseline to Weeks 1, 4, and 8
Other outcomes:
Locations:
city: Andover
country: United States
facility: Ora Inc, 300 Brickstone Square,
state: Massachusetts
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: