Dry EyePhase 2NCT01250171
The Effects of a Single Intravenous Administration of Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Patients
A Phase 2 study testing Secukinumab 10 mg/kg and Canakinumab 10 mg/kg in people with Dry Eye, run by Novartis Pharmaceuticals at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dry Eye
- What is being tested?
- Secukinumab 10 mg/kg and Canakinumab 10 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Sep 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ora Inc, 300 Brickstone Square,
Andover, Massachusetts, 01810
About this study
Official title: 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.
- Conditions
- Dry Eye
- Being tested
- Secukinumab 10 mg/kg, Canakinumab 10 mg/kg, Placebo
- Keywords
- Dry eye, IL17/ IL-1β, Biologic
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secukinumab 10 mg/kgBiological
Also called AIN457
Secukinumab was prepared in a sterile water solution.
Canakinumab 10 mg/kgBiological
Also called ACZ885
Canakinumab was prepared in a sterile water solution.
PlaceboBiological
The placebo solution for infusion contained 5% glucose.
| Study group | Role | What they receive |
|---|---|---|
| Secukinumab 10 mg/kg | Experimental | Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period. Receives: Biological: Secukinumab 10 mg/kg |
| Canakinumab 10 mg/kg | Experimental | Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period. Receives: Biological: Canakinumab 10 mg/kg |
| Placebo | Placebo comparator | Patients received a single placebo infusion intravenously over a 2 hour period. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at 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.
Measured: Baseline to Week 4
Secondary outcomes (7)
Change From Baseline on the Ora Corneal Staining Scale at 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.
Measured: Baseline to Weeks 1, 4, and 8
Change From Baseline on the Schirmer Test at 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.
Measured: Baseline to Weeks 1, 4, and 8
Change From Baseline in Tear Film Breakup Time at 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.
Measured: Baseline to Weeks 1, 4, and 8
Change From Baseline on the Conjunctival Redness Scale (Ora) at 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.
Measured: Baseline to Weeks 1, 4, and 8
Change From Baseline in the Ocular Surface Disease Index (OSDI) at 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.
Measured: Baseline to Weeks 1, 4, and 8
Desire for Artificial Tear Use at 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.
Measured: Day 1 and Weeks 1, 4, and 8
Change From Baseline in Best Corrected Visual Acuity at 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.
Measured: Baseline to Weeks 1, 4, and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01250171
- Sponsor's protocol ID
- CPJMR0092202
- Status last verified
- Dec 2012
- First submitted
- 29 Nov 2010
- Last updated
- 7 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Double-blind, Proof-of-concept Study of Intravenous Secukinumab (AIN457) or Canakinumab (ACZ885) in Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT01250171
- Acronym / sponsor ID
- CPJMR0092202
- Conditions
- Dry Eye
- Keywords
- Dry eye, IL17/ IL-1β, Biologic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Posted 7 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Secukinumab 10 mg/kg | Experimental | Biological: Secukinumab 10 mg/kgPatients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period. |
| Canakinumab 10 mg/kg | Experimental | Biological: Canakinumab 10 mg/kgPatients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period. |
| Placebo | Placebo comparator | Biological: PlaceboPatients received a single placebo infusion intravenously over a 2 hour period. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Secukinumab 10 mg/kgAlso: AIN457Secukinumab was prepared in a sterile water solution. | Biological | Secukinumab 10 mg/kg |
| Canakinumab 10 mg/kgAlso: ACZ885Canakinumab was prepared in a sterile water solution. | Biological | Canakinumab 10 mg/kg |
| PlaceboThe placebo solution for infusion contained 5% glucose. | Biological | Placebo |
Primary outcome
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.
7 secondary outcomes
Change From Baseline on the Ora Corneal Staining Scale at Weeks 1, 4, and 8
Time frame: 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
Change From Baseline in Tear Film Breakup Time at Weeks 1, 4, and 8
Time frame: 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
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
Desire for Artificial Tear Use at Day 1 and Weeks 1, 4, and 8
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Secukinumab 10 mg/kg and Canakinumab 10 mg/kg in people with Dry Eye, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline on the National Eye Institute Corneal Staining Scale (NEI-CSS) at Week 4 (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2013.