Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm 1 | Active Comparator | 2.5% IL-1Ra |
|
| Placebo | Placebo Comparator | Artificial Tear |
|
| Treatment Arm 2 | Active Comparator | 5% IL-1Ra |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2.5% IL-1Ra | Drug | 2.5% custom made topical IL-1Ra three times a day in both eyes for three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Meibomian Gland Secretion Quality | Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality) | 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. | 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. | 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. | Baseline and 12 Week Time Point data |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Reza Dana, MD, MPH, MSc | Massachusetts Eye and Ear Infirmary | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23599118 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 2.5% IL-1Ra | Anakinra (IL-1Ra) 2.5% Topical Ophthalmic Solution three times per day. |
| FG001 | Placebo | Artificial Tear Topical Ophthalmic Solution three times per day. |
| FG002 | 5% IL-1Ra | Anakinra (IL-1Ra) 5% Topical Ophthalmic Solution three times per day. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 2.5% IL-1Ra | Anakinra 2.5% Topical Ophthalmic Solution |
| BG001 | Placebo | Artificial Tear Topical Ophthalmic Solution |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Meibomian Gland Secretion Quality | Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality) | Posted | Mean | Standard Deviation | Units on a scale | 12 Week Time Point |
|
16 Weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2.5% IL-1Ra | Anakinra 2.5% Topical Ophthalmic Solution | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Blood and lymphatic system disorders | Systematic Assessment | Subject died due to complications resulting from chronic myelocytic leukemia |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stinging Eye | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Reza Dana | Massachusetts Eye and Ear Infirmary | (617) 573-4331 | Reza_Dana@meei.harvard.edu |
| ID | Term |
|---|---|
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D053590 | Interleukin 1 Receptor Antagonist Protein |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | custom eye drop to be applied three times a day in both eyes for three months |
|
|
| 5% IL-1Ra | Drug | 5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months |
|
|
| BG002 | 5% IL-1Ra | Anakinra 5% Topical Ophthalmic Solution |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Meibomian Gland Secretion Quality | Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality) | Mean | Standard Deviation | units on a scale |
|
| Tear Film Break-Up 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. | Mean | Standard Deviation | Seconds |
|
| Corneal Fluorescein Staining Score | CFS 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. | Mean | Standard Deviation | units on a scale |
|
| 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. OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Seconds | 12 Week Time Point |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | 12 Week Time Point |
|
|
|
| Primary | 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. | The OSDI analysis for this study is based on a standard intention-to-treat analysis with each study participant analyzed with respect to the randomized treatment assignment, regardless of eventual compliance. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 Week Time Point data |
|
|
|
| 30 |
| 1 |
| 30 |
| 11 |
| 30 |
| EG001 | Placebo | Artificial Tear Topical Ophthalmic Solution | 0 | 30 | 0 | 30 | 17 | 30 |
| EG002 | 5% IL-1Ra | Anakinra 5% Topical Ophthalmic Solution | 0 | 15 | 0 | 15 | 2 | 15 |
|
| Burning Eye | Eye disorders | Systematic Assessment |
|
| Grittiness | Eye disorders | Systematic Assessment |
|
| Itching Eye | Eye disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Epiphora | Eye disorders | Systematic Assessment |
|
| Discomfort (unspecific) | Eye disorders | Systematic Assessment |
|
| Eyelid Irritation | Eye disorders | Systematic Assessment |
|
| Pingueculitis | Eye disorders | Systematic Assessment |
|
| Blepharospasm | Eye disorders | Systematic Assessment |
|
| Episcleritis | Eye disorders | Systematic Assessment |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D011506 | Proteins |
| D001685 | Biological Factors |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |