Posterior BlepharitisPhase 1/2NCT00681109
Topical IL-1-Ra for Treatment of Posterior Blepharitis
A Phase 1/2 study testing 2.5% IL-1Ra and 5% IL-1Ra in people with Posterior Blepharitis, run by Reza Dana, MD.
Trial summary
The purpose of this study is to determine the effectiveness and safety of Topical Interleukin-1-Receptor Antagonist in treatment of signs and symptoms of posterior blepharitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posterior Blepharitis
- What is being tested?
- 2.5% IL-1Ra and 5% IL-1Ra
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Oct 2010
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of posterior blepharitis
- A negative urine pregnancy test result for women of childbearing potential
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
- Normal lid position and closure
- Ability to understand and provide informed consent to participate in this study
- Willingness to follow study instructions and likely to complete all required visits.
Who cannot join
- History of Stevens-Johnson syndrome or ocular pemphigoid
- History of eyelid surgery
- Intra-ocular surgery or ocular laser surgery within 3 months
- History of microbial keratitis, including herpes
- Active ocular allergies
- Corneal epithelial defect > 1mm2
Show all 14Show fewer
- Use of topical steroids or Restasis within the past 2 weeks
- Use of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month
- Use of isotretinoin (Accutane) within the past 6 months
- Have had any previous treatment with Anakinra (Kineret®) or any therapeutic agent targeted at IL-1 blockade
- Pregnant or lactating women
- Signs of current infection, including fever and current treatment with antibiotics
- Liver, renal, or hematologic disease
- The use of any other investigational drug
About this study
Official title: Safety and Efficacy of Topical Interleukin-1-Receptor Antagonist in the Treatment of Signs and Symptoms of Posterior Blepharitis
The purpose of this study is to determine the effectiveness and safety of Topical Interleukin-1-Receptor Antagonist in treatment of signs and symptoms of posterior blepharitis.
- Conditions
- Posterior Blepharitis
- Being tested
- 2.5% IL-1Ra, Placebo, 5% IL-1Ra
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5% IL-1RaDrug
Also called Anakinra 2.5%, Kineret 2.5%
2.5% custom made topical IL-1Ra three times a day in both eyes for three months
PlaceboDrug
Also called Artificial Tear
custom eye drop to be applied three times a day in both eyes for three months
5% IL-1RaDrug
Also called Anakinra 5%, Kineret 5%
5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Active comparator | 2.5% IL-1Ra Receives: Drug: 2.5% IL-1Ra |
| Placebo | Placebo comparator | Artificial Tear Receives: Drug: Placebo |
| Treatment Arm 2 | Active comparator | 5% IL-1Ra Receives: Drug: 5% IL-1Ra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meibomian Gland Secretion Quality
Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)
Measured: 12 Week Time Point
Tear Breakup Time (TBUT)
TBUT measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time.
Measured: 12 Week Time Point
Corneal Fluorescein Staining Score
Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.
Measured: 12 Week Time Point
Ocular Surface Disease Index (OSDI)
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The 12 items of the OSDI questionnaire are graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score is then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) x 100]/[(total number of questions answered) x 4].
Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. A negative change from baseline indicated an improvement in vision-related functioning.
OSDI was assessed on the Baseline Visit, Week 2, Week 6, Week 12, Week 16. Change indicated represents change from Baseline to Week 12.
Measured: Baseline and 12 Week Time Point data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startJan 2008
- Primary completionMay 2010
- Study completionOct 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Posterior BlepharitisStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reza Dana, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reza Dana, MD, Massachusetts Eye and Ear Infirmary
- Investigators
- Reza Dana, MD, MPH, MSc, Principal investigator, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681109
- Sponsor's protocol ID
- 07-07-047
- Status last verified
- Dec 2017
- First submitted
- 19 May 2008
- Last updated
- 19 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Amparo F, Dastjerdi MH, Okanobo A, Ferrari G, Smaga L, Hamrah P, Jurkunas U, Schaumberg DA, Dana R. Topical interleukin 1 receptor antagonist for treatment of dry eye disease: a randomized clinical trial. JAMA Ophthalmol. 2013 Jun;131(6):715-723. doi: 10.1001/jamaophthalmol.2013.195.
PubMed 23599118
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Topical Interleukin-1-Receptor Antagonist in the Treatment of Signs and Symptoms of Posterior Blepharitis
- ClinicalTrials.gov ID
- NCT00681109
- Acronym / sponsor ID
- 07-07-047
- Conditions
- Posterior Blepharitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Reza Dana, MDUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- May 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Posted 27 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness and safety of Topical Interleukin-1-Receptor Antagonist in treatment of signs and symptoms of posterior blepharitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Active comparator | Drug: 2.5% IL-1Ra2.5% IL-1Ra |
| Placebo | Placebo comparator | Drug: PlaceboArtificial Tear |
| Treatment Arm 2 | Active comparator | Drug: 5% IL-1Ra5% IL-1Ra |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A diagnosis of posterior blepharitis
- A negative urine pregnancy test result for women of childbearing potential
- Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation
- Normal lid position and closure
- Ability to understand and provide informed consent to participate in this study
Key exclusion criteria (14 listed)
- History of Stevens-Johnson syndrome or ocular pemphigoid
- History of eyelid surgery
- Intra-ocular surgery or ocular laser surgery within 3 months
- History of microbial keratitis, including herpes
- Active ocular allergies
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 |
|---|---|---|
| 2.5% IL-1RaAlso: Anakinra 2.5%, Kineret 2.5%2.5% custom made topical IL-1Ra three times a day in both eyes for three months | Drug | Treatment Arm 1 |
| PlaceboAlso: Artificial Tearcustom eye drop to be applied three times a day in both eyes for three months | Drug | Placebo |
| 5% IL-1RaAlso: Anakinra 5%, Kineret 5%5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months | Drug | Treatment Arm 2 |
Primary outcome
Meibomian Gland Secretion Quality
Time frame: 12 Week Time Point
Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)
Tear Breakup Time (TBUT)
Time frame: 12 Week Time Point
TBUT measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time.
Corneal Fluorescein Staining Score
Time frame: 12 Week Time Point
Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.
Ocular Surface Disease Index (OSDI)
Time frame: Baseline and 12 Week Time Point data
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The 12 items of the OSDI questionnaire are graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score is then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) x 100]/[(total number of questions answered) x 4]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. A negative change from baseline indicated an improvement in vision-related functioning. OSDI was assessed on the Baseline Visit, Week 2, Week 6, Week 12, Week 16. Change indicated represents change from Baseline to Week 12.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23599118Amparo F, Dastjerdi MH, Okanobo A, Ferrari G, Smaga L, Hamrah P, Jurkunas U, Schaumberg DA, Dana R. Topical interleukin 1 receptor antagonist for treatment of dry eye disease: a randomized clinical trial. JAMA Ophthalmol. 2013 Jun;131(6):715-723. doi: 10.1001/jamaophthalmol.2013.195.
- Individual participant dataSharing planned: No
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Autologous Serum Obtained by a Closed-Circuit Collection Device
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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.
Reza Dana, MD, MPH, MSc principal investigator
Massachusetts Eye and Ear Infirmary
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 2.5% IL-1Ra and 5% IL-1Ra in people with Posterior Blepharitis, run by Reza Dana, MD.
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 6 inclusion and 14 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 19 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 27 Nov 2012). 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?
Meibomian Gland Secretion Quality (time frame: 12 Week Time Point). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00681109, which also lists 1 linked publication.
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 19 Jan 2018.