- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01250171
The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients
December 4, 2012 updated by: Novartis Pharmaceuticals
A Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Intravenous Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Syndrome
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Andover, Massachusetts, United States, 01810
- Ora Inc, 300 Brickstone Square,
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Secukinumab 10 mg/kg
Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
|
Secukinumab was prepared in a sterile water solution.
Other Names:
|
Experimental: Canakinumab 10 mg/kg
Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
|
Canakinumab was prepared in a sterile water solution.
Other Names:
|
Placebo Comparator: Placebo
Patients received a single placebo infusion intravenously over a 2 hour period.
|
The placebo solution for infusion contained 5% glucose.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4
Time Frame: Baseline to Week 4
|
Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of each eye.
Staining was assessed in 5 zones of the cornea (central plus 4 quadrants) and rated on a scale of 0 (no staining) to 3 (severe, confluent staining).
A mean of the 5 zones for the study eye was calculated.
A higher score indicates a drier eye.
A negative change score indicates improvement in dryness.
|
Baseline to Week 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline on the Ora Corneal Staining Scale at Weeks 1, 4, and 8
Time Frame: Baseline to Weeks 1, 4, and 8
|
Corneal staining was done with 2% sodium fluorescein instilled into the lower palpebral conjunctiva of the study eye.
Staining was assessed in 3 regions (inferior, superior, and central) of the cornea and rated on a scale of 0 (no staining) to 4 (confluent staining).
A mean of the 3 zones was calculated.
A higher score indicates a drier eye.
A negative change score indicates improvement in dryness.
|
Baseline to Weeks 1, 4, and 8
|
Change From Baseline on the Schirmer Test at Weeks 1, 4, and 8
Time Frame: Baseline to Weeks 1, 4, and 8
|
The Schirmer test measures the production of tears.
A small strip of filter paper is placed inside the lower eyelid (conjunctival sac) of each eye and the eyes are kept closed for 5 minutes.
The paper is removed and the length of paper that is wet is measured as an index of tear production.
The amount of tear production in the study eye was ranked on a 4 point scale: 0=Normal (≥ 15 mm wetting of the paper), 1=Mild (14-9 mm wetting of the paper), 2=Moderate (8-4 mm wetting of the paper), and 3=Severe (< 4 mm wetting of the paper).
A higher score indicates a drier eye.
A negative change score indicates improvement in dryness.
|
Baseline to Weeks 1, 4, and 8
|
Change From Baseline in Tear Film Breakup Time at Weeks 1, 4, and 8
Time Frame: Baseline to Weeks 1, 4, and 8
|
Tear film breakup time was defined as the time of last blink to the appearance of the first growing micelle after instilling 5 μl of non-preserved 2% sodium fluorescein into the lower palpebral conjunctiva of the study eye.
Measurement was repeated 3 times and a mean tear film breakup time calculated.
A lower score indicates a drier eye.
A positive change score indicates improvement in dryness.
|
Baseline to Weeks 1, 4, and 8
|
Change From Baseline on the Conjunctival Redness Scale (Ora) at Weeks 1, 4, and 8
Time Frame: Baseline to Weeks 1, 4, and 8
|
Conjunctival redness was measured in the study eye at each visit by a masked evaluator.
The evaluator compared the patient's study eye with a set of 5 reference photos showing a normal eye and eyes with various degrees of redness.
Redness was scored on a scale of 0-5 with a white normal eye = 0 and an eye with the most redness = 5.
A higher score indicates more redness.
A negative change score indicates improvement in redness.
|
Baseline to Weeks 1, 4, and 8
|
Change From Baseline in the Ocular Surface Disease Index (OSDI) at Weeks 1, 4, and 8
Time Frame: Baseline to Weeks 1, 4, and 8
|
The OSDI is an instrument for measuring dry eye disease severity and effect on vision-related functions.
Patients were asked a series of 12 questions; patients responded to the questions in regard to both eyes.
Responses ranged from 0=None of the time to 4=All of the time.
OSDI was calculated as the sum of the 12 question scores x 25/number of questions answered.
The total score ranged from 0-100.
A higher score indicates drier eyes.
A negative change score indicates improvement in dryness.
|
Baseline to Weeks 1, 4, and 8
|
Desire for Artificial Tear Use at Day 1 and Weeks 1, 4, and 8
Time Frame: Day 1 and Weeks 1, 4, and 8
|
Patients were instructed to record each occurrence of a desire for topical lubricant use in a patient diary.
The percentage of patients in each of 6 categories (0-5, 6-10, 11-15, 16-20, 21-25, > 25 times) indicating the number of times a patient records a desire for artificial tear use per day was calculated at each time point.
The percentage was calculated using the number of patients with any reported data on that day in the respective treatment group as the denominator.
|
Day 1 and Weeks 1, 4, and 8
|
Change From Baseline in Best Corrected Visual Acuity at Weeks 1, 4, and 8
Time Frame: Baseline to Weeks 1, 4, and 8
|
Best corrected visual acuity (BCVA) was assessed in the study eye.
BCVA measurements were taken in a standing position using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at an initial testing distance specific to the test charts.
The BCVA score is the number of letters read correctly by the patient.
A decrease in the BCVA score indicates a worsening of vision.
A positive change score indicates improvement.
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Baseline to Weeks 1, 4, and 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
November 29, 2010
First Submitted That Met QC Criteria
November 29, 2010
First Posted (Estimate)
November 30, 2010
Study Record Updates
Last Update Posted (Estimate)
January 7, 2013
Last Update Submitted That Met QC Criteria
December 4, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPJMR0092202
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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