A Phase 1/2 interventional study of 2.5% IL-1Ra and Placebo in Posterior Blepharitis, sponsored by Reza Dana, MD. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-19.
Sponsored by Reza Dana, MD · Phase 1/2, Interventional, and Treatment
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.
172 studies on the registry are indexed under Meibomian Gland Dysfunction; 23 are open to participants now.
This study's enrollment of 75 is above the median of 50 across 138 interventional studies indexed under Meibomian Gland Dysfunction.
Browse Meibomian Gland Dysfunction studies →Reza Dana, MD is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2.5% IL-1Ra
Drug: 2.5% IL-1Ra
Artificial Tear
Drug: Placebo
5% IL-1Ra
Drug: 5% IL-1Ra
2.5% custom made topical IL-1Ra three times a day in both eyes for three months
Also known as: Anakinra 2.5%, Kineret 2.5%
custom eye drop to be applied three times a day in both eyes for three months
Also known as: Artificial Tear
5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months
Also known as: Anakinra 5%, Kineret 5%
Meibomian Gland Secretion Quality
Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 Week Time Point data
| Milestone | 2.5% IL-1Ra | Placebo | 5% IL-1Ra |
|---|---|---|---|
| Started | 30 | 30 | 15 |
| Completed | 28 | 24 | 15 |
| Not completed | 2 | 6 | 0 |
| Withdrew: Lost to follow-up | 2 | 6 | 0 |
Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)
| Units on a scale | 2.5% IL-1Ra | Placebo | 5% IL-1Ra |
|---|---|---|---|
| Meibomian Gland Secretion Quality | 1.7 ± 0.7 | 1.7 ± 0.4 | 1.8 ± 0.6 |
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.
| Seconds | 2.5% IL-1Ra | Placebo | 5% IL-1Ra |
|---|---|---|---|
| Tear Breakup Time (TBUT) | 4.5 ± 2.8 | 4.4 ± 2.3 | 3.9 ± 2.0 |
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.
| Units on a scale | 2.5% IL-1Ra | Placebo | 5% IL-1Ra |
|---|---|---|---|
| Corneal Fluorescein Staining Score | 0.9 ± 0.7 | 1.4 ± 1.1 | 1.4 ± 0.8 |
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.
| units on a scale | Anakinra 2.5% Topical Ophthalmic Solution | Artificial Tear Topical Ophthalmic Solution | Anakinra 5% Topical Ophthalmic Solution |
|---|---|---|---|
| Ocular Surface Disease Index (OSDI) | 31.8 ± 24.1 | 41.8 ± 24.1 | 31.7 ± 19.0 |
Collected over 16 Weeks. Non-serious events are listed at a 3.3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 2.5% IL-1Ra | 1/30 (3.3%) | 1/30 (3.3%) | 11/30 (36.7%) |
| Placebo | 0/30 (0%) | 0/30 (0%) | 17/30 (56.7%) |
| 5% IL-1Ra | 0/15 (0%) | 0/15 (0%) | 2/15 (13.3%) |
| Event | 2.5% IL-1Ra | Placebo | 5% IL-1Ra |
|---|---|---|---|
| DeathBlood and lymphatic system disorders | 1/30 | 0/30 | 0/15 |
| Event | 2.5% IL-1Ra | Placebo | 5% IL-1Ra |
|---|---|---|---|
| Burning EyeEye disorders | 1/30 | 3/30 | 0/15 |
| GrittinessEye disorders | 3/30 | 0/30 | 0/15 |
| Blurred VisionEye disorders | 2/30 | 2/30 | 1/15 |
| Discomfort (unspecific)Eye disorders | 0/30 | 2/30 | 0/15 |
| Eyelid IrritationEye disorders | 1/30 | 2/30 | 0/15 |
| PingueculitisEye disorders | 0/30 | 2/30 | 0/15 |
| BlepharospasmEye disorders | 0/30 | 2/30 | 0/15 |
| ConjunctivitisEye disorders | 1/30 | 1/30 | 1/15 |
| Stinging EyeEye disorders | 1/30 | 1/30 | 0/15 |
| Itching EyeEye disorders | 1/30 | 1/30 | 0/15 |
| Age, Continuous(years) | 2.5% IL-1Ra | Placebo | 5% IL-1Ra | Total |
|---|---|---|---|---|
| Mean | 49 ± 14 | 53 ± 12 | 58 ± 16 | 52 ± 14 |
| Sex: Female, Male(Participants) | 2.5% IL-1Ra | Placebo | 5% IL-1Ra | Total |
|---|---|---|---|---|
| Female | 18 | 16 | 10 | 44 |
| Male | 12 | 14 | 5 | 31 |
| Region of Enrollment(participants) | 2.5% IL-1Ra | Placebo | 5% IL-1Ra | Total |
|---|---|---|---|---|
| United States | 30 | 30 | 15 | 75 |
| Meibomian Gland Secretion Quality(units on a scale) | 2.5% IL-1Ra | Placebo | 5% IL-1Ra | Total |
|---|---|---|---|---|
| Mean | 1.9 ± 0.4 | 1.8 ± 0.5 | 1.9 ± 0.5 | 1.9 ± 0.5 |
| Tear Film Break-Up Time (TBUT)(Seconds) | 2.5% IL-1Ra | Placebo | 5% IL-1Ra | Total |
|---|---|---|---|---|
| Mean | 3.8 ± 2.8 | 3.8 ± 2.1 | 3.5 ± 2.2 | 3.7 ± 2.5 |
| Corneal Fluorescein Staining Score(units on a scale) | 2.5% IL-1Ra | Placebo | 5% IL-1Ra | Total |
|---|---|---|---|---|
| Mean | 1.6 ± 0.9 | 1.7 ± 1.2 | 1.7 ± 0.9 | 1.7 ± 1.0 |
| Ocular Surface Disease Index (OSDI)(units on a scale) | 2.5% IL-1Ra | Placebo | 5% IL-1Ra | Total |
|---|---|---|---|---|
| Mean | 44.2 ± 20.4 | 45.6 ± 21.1 | 48.5 ± 21.0 | 46.1 ± 20.4 |
No study locations are listed for this record.
Plan to share: No
The record gives a start of Jan 2008, a primary completion of May 2010 and a completion of Oct 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Nov 2012, 2 years 6 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Interleukin 1 Receptor Antagonist Protein
Reza Dana, MD