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| Name | Class |
|---|---|
| Kresge Eye Institute | OTHER |
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Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing.
The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May, 2010).
The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface healing, may be able to promote healing of the corneal surface allowing for more conventional modalities to take over and maintain a smooth and regular ocular surface. The investigators hope to be able to demonstrate an improvement in visual acuity, surface healing and a reduction in dry-eye related symptoms.
See above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thymosin Beta 4 eye drops | Experimental | It is a preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, six times daily for 28 days |
|
| Vehicle Control | Placebo Comparator | It is composed of the same excipients as RGN-259 but does not contain Tβ4 for direct instillation into each eye, six times daily for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymosin Beta 4 eye drops | Drug | Patients will be randomized and will receive the same eye drops the Thymosin Beta 4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety | Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits). | Day 1, Day 14, Day 28 and Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Fluorescein Staining | Ocular surface irregularity as measured by Slit Lamp Examination (SLE) with fluorescein dye staining of the cornea at days 56 (+28 day follow up). The scale used to determine the difference in corneal fluorescein staining is the Oxford scale. (The Oxford Scale measures corneal fluorescein staining) Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The five regions were summed, for a maximum score of 25. A higher score represents greater disability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven P Dunn, M.D. | Michigan Cornea Consultants, P.C. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michigan Cornea Consultants, P.C. | Southfield | Michigan | 48034 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25826322 | Derived | Sosne G, Dunn SP, Kim C. Thymosin beta4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial. Cornea. 2015 May;34(5):491-6. doi: 10.1097/ICO.0000000000000379. |
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Pre-assignment Details:
Subjects were evaluated upon entering the study after a two week washout period.
Recruitment Details The study took place at Kresge Eye Institute by Dr. Gabriel Sosne, and at Michigan Cornea Consultants, P.C. by Dr. Steven P. Dunn,
The first subject was screened on Mar.2011 and the last subject last visit to the clinic was on Dec.2012
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| ID | Title | Description |
|---|---|---|
| FG000 | Thymosin | Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days. Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days. Period Title * Participant Flow: Overall Study Placebo Thymosin Beta 4 Started 3 6 Completed 3 6 |
| FG001 | Placebo | Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Thymosin | Comparison Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Safety | Sum of adverse events observed at Day 1, Day 14, Day 28 and Day 56. Measurable by Intra-ocular pressure (IOP) by applanation tonometry, Complete ophthalmologic evaluation including fundoscopy, An adverse event (baseline and all subsequent study visits). | Posted | Number | event | Day 1, Day 14, Day 28 and Day 56 |
|
56 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Thymosin Beta 4 | Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabriel Sosne, MD | Wayne State Univeristy, Detroit, MI | 248-594-6702 | gsosne@med.wayne.edu |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D012859 | Sjogren's Syndrome |
| D006086 | Graft vs Host Disease |
| D001172 | Arthritis, Rheumatoid |
| D008180 | Lupus Erythematosus, Systemic |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
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| Vehicle Control | Drug | Patients will be randomized and will receive the same eye drops without the Thymosin Beta 4. |
|
|
| Days 56 (+28 day follow up) |
| Ocular Discomfort Index | Dry eye causes ocular discomfort, which is measured using a Ocular Surface Disease Index at 56 day (+28 day followup). (Symptomatic improvement using the validated Ocular Surface Disease Index (OSDI). The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. | Days 56 (+28 day follow up) |
| Tear Film Break up Time | Tear film break up time (TFBUT) was measured to evaluating the quality of tear at 56 day (+28 day follow up). The tear film break-up time is defined as the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Range : >10 seconds is thought to be normal, <5 seconds low (with high likelihood of dry eye symptoms). | Days 56 (+28 day follow up) |
Comparison
Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Corneal Fluorescein Staining | Ocular surface irregularity as measured by Slit Lamp Examination (SLE) with fluorescein dye staining of the cornea at days 56 (+28 day follow up). The scale used to determine the difference in corneal fluorescein staining is the Oxford scale. (The Oxford Scale measures corneal fluorescein staining) Corneal staining type was assessed by the investigator for each of 5 regions of the cornea, i.e., four quadrants plus central. The five regions were summed, for a maximum score of 25. A higher score represents greater disability. | Posted | Mean | Standard Deviation | units on a scale | Days 56 (+28 day follow up) |
|
|
|
|
| Secondary | Ocular Discomfort Index | Dry eye causes ocular discomfort, which is measured using a Ocular Surface Disease Index at 56 day (+28 day followup). (Symptomatic improvement using the validated Ocular Surface Disease Index (OSDI). The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time. OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. | Posted | Mean | Standard Deviation | units on a scale | Days 56 (+28 day follow up) |
|
|
|
|
| Secondary | Tear Film Break up Time | Tear film break up time (TFBUT) was measured to evaluating the quality of tear at 56 day (+28 day follow up). The tear film break-up time is defined as the interval between the last complete blink and the first appearance of a dry spot, or disruption in the tear film. Range : >10 seconds is thought to be normal, <5 seconds low (with high likelihood of dry eye symptoms). | Posted | Mean | Standard Deviation | seconds | Days 56 (+28 day follow up) |
|
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Placebo | : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days | 0 | 3 | 0 | 3 |
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| D009140 |
| Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012595 | Scleroderma, Systemic |
| D012871 | Skin Diseases |