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Sponsor ceased sponsorship and terminated the research citing slow accrual of subjects in this clinical trial.
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| Name | Class |
|---|---|
| Research to Prevent Blindness | OTHER |
| Genentech, Inc. | INDUSTRY |
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The purpose of this study is to evaluate the tolerability and preliminary efficacy of DNase eye drops in patients with Sjogren's and Non-Sjogren Dry Eye Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DNase | Active Comparator | DNase 0.1% eye drops four times a day for 8 weeks |
|
| Vehicle | Placebo Comparator | Drug vehicle eye drops four times a day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DNase | Drug | DNase 0.1% eye drops four times a day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining | Corneal staining score as measured by Rose Bengal (RB) dye staining using National Eye Institute (NEI) 1995 workshop grading scale. The dye was applied to each eye and a slit lamp was used to observe corneal staining. The NEI scale relies on a chart that divides the cornea into 5 sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the density of punctate staining, final staining score being the sum of individual section scores, for a range of 0 (minimum) -15 (maximum) points. Complete corneal staining clearance with RB dye defined as a score of 0 indicating the best outcome. | Between baseline and at 8 weeks of treatment |
| The Change in the Ocular Surface Disease Index Score | Ocular Surface Disease Index (OSDI), a 12-item questionnaire, assesses symptom of ocular irritation in dry eye disease (DED) and how it affects functioning related to vision in the past week. It has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on 0 to 4 scale with 0 being "none of the time" and 4 being "all of the time." OSDI score range from 0-100 with score 0-12 being normal, 13-22 being mild DED, 23-32 being moderate DED, and >33 being severe DED. OSDI=[(sum of scores for questions answered)×100]/[(total questions answered)×4] | Between baseline and at 8 weeks of treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| The Change in Mucoid Debris Strands Between Baseline and 8-weeks | The presence of mucoid debris/strands over the ocular surface was assessed and the amount graded as the absence of mucoid debris (0) or presence of mucoid debris (1+, 2+ or 3+) with a bigger number indicating greater presence of mucoid debris with "3+" implying presence of the highest amount of mucoid debris and indicating the worst outcome. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandeep Jain, MD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Translational Clinic of Corneal Neurobiology laboratory, Illinois Eye and Ear Infirmary, University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24255046 | Background | Tibrewal S, Sarkar J, Jassim SH, Gandhi S, Sonawane S, Chaudhary S, Byun YS, Ivanir Y, Hallak J, Horner JH, Newcomb M, Jain S. Tear fluid extracellular DNA: diagnostic and therapeutic implications in dry eye disease. Invest Ophthalmol Vis Sci. 2013 Dec 11;54(13):8051-61. doi: 10.1167/iovs.13-12844. | |
| 23169882 | Background |
| Label | URL |
|---|---|
| Principal Investigator description | View source |
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A 2-week washout period was required if topical corticosteroids or topical cyclosporine were discontinued before enrollment.
This single-center study was conducted at the Department of Ophthalmology Clinical Trials and Translational Center, the University of Illinois at Chicago (UIC).
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| ID | Title | Description |
|---|---|---|
| FG000 | DNase | DNase 0.1% eye drops four times a day for 8 weeks DNase: DNase 0.1% eye drops four times a day for 8 weeks |
| FG001 | Vehicle | Drug vehicle eye drops four times a day for 8 weeks Vehicle: Drug vehicle eye drops four times a day for 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DNase | DNase 0.1% eye drops four times a day for 8 weeks DNase: DNase 0.1% eye drops four times a day for 8 weeks |
| BG001 | Vehicle | Drug vehicle eye drops four times a day for 8 weeks Vehicle: Drug vehicle eye drops four times a day for 8 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining | Corneal staining score as measured by Rose Bengal (RB) dye staining using National Eye Institute (NEI) 1995 workshop grading scale. The dye was applied to each eye and a slit lamp was used to observe corneal staining. The NEI scale relies on a chart that divides the cornea into 5 sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the density of punctate staining, final staining score being the sum of individual section scores, for a range of 0 (minimum) -15 (maximum) points. Complete corneal staining clearance with RB dye defined as a score of 0 indicating the best outcome. | Posted | Median | Inter-Quartile Range | score on a scale | Between baseline and at 8 weeks of treatment |
|
Between baseline and 8-weeks of treatment.
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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 | DNase | DNase 0.1% eye drops four times a day for 8 weeks DNase: DNase 0.1% eye drops four times a day for 8 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Grittines | Eye disorders | Non-systematic Assessment |
Outcomes of this clinical trial shouldn't be over-interpreted for benefit. Accurate assessment of therapeutic implications of DNase eye drops will only be possible after adequately powered definitive pivotal trials. Small sample size is a limitation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sandeep Jain | University of Illinois Chicago | 312-996-4476 | jains@uic.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2015 | Jul 23, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003851 | Deoxyribonucleases |
| C568813 | dornase alfa |
| ID | Term |
|---|---|
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| Vehicle | Drug | Drug vehicle eye drops four times a day for 8 weeks |
|
|
| Between baseline and 8-weeks of treatment |
| Sonawane S, Khanolkar V, Namavari A, Chaudhary S, Gandhi S, Tibrewal S, Jassim SH, Shaheen B, Hallak J, Horner JH, Newcomb M, Sarkar J, Jain S. Ocular surface extracellular DNA and nuclease activity imbalance: a new paradigm for inflammation in dry eye disease. Invest Ophthalmol Vis Sci. 2012 Dec 17;53(13):8253-63. doi: 10.1167/iovs.12-10430. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis | Count of Participants | Participants |
|
| OSDI | Ocular Surface Disease Index (OSDI), 12-item questionnaire, assesses symptom of ocular irritation in dry eye disease (DED) and how it affects functioning related to vision in past week. It has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on 0 to 4 scale with 0 being "none of the time" and 4 being "all of the time." OSDI score range from 0-100 with score 0-12 being normal, 13-22 being mild DED, 23-32 being moderate DED, and >33 being severe DED. OSDI=[(sum of scores for questions answered)×100]/[(total questions answered)×4] | Median | Inter-Quartile Range | units on a scale |
|
| Corneal Staining | Corneal staining score as measured by Rose Bengal (RB) dye staining using National Eye Institute (NEI) grading scale. The dye was applied to each eye and a slit lamp was used to observe corneal staining. The NEI scale relies on a chart that divides the cornea into 5 sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the density of punctate staining, final staining score being the sum of individual section scores with a range of 0 (minimum) -15 (maximum) points. Complete corneal staining clearance with RB dye defined as a score of 0 indicating the best outcome. | Median | Inter-Quartile Range | units on a scale |
|
| Mucoid Debris Strands | Count of Participants | Participants |
|
| Schirmer I | The Schirmer's I tests consists of a thin strip of filter paper placed in lower conjunctival fornix (between the lower eyelid and ocular surface) for 5 minutes. The length of wetting of the strip is used as a measure of tear production by the eye. A normal level of production is considered to be over 10 millimeters (mm) of tears on the paper. Anything under 10 mm is considered to be an abnormally low level of tear production. A measurement of less than 5 mm is considered severe dry eye. | Median | Inter-Quartile Range | mm |
|
| Conjunctival Staining | Conjunctival staining score as measured by Rose Bengal (RB) dye staining using National Eye Institute (NEI) grading scale. The dye was applied to each eye and a slit lamp was used to observe conjunctival staining. The NEI scale relies on a chart that divides the conjunctiva into 2 sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the density of punctate staining, final staining score being the sum of individual section scores, for a range of 0-6 points. Complete conjunctival staining clearance with RB dye defined as a score of 0 indicating the best outcome. | Median | Inter-Quartile Range | units on a scale |
|
| Conjunctival Injection | Ocular surface redness (nasal or temporal) will be assessed using the Validated Bulbar Redness grading scale (VBR). VBR consists of 10 images illustrating different degrees of ocular surface redness (OR), ranging from normal to severe, and each image is assigned a value in an order of ascending severity (10-100). Subjects were examined by a slit-lamp and the bulbar conjunctival injection of the subject's eye (nasal and temporal) will be compared to the reference images and graded accordingly. | Median | Inter-Quartile Range | units on a scale |
|
| Corneal Filaments | Count of Participants | Participants |
|
| Tolerability [Oculus Uterque (OU)] | To see how subjects react to the study medication, their first dose was given by the investigator at baseline visit in the clinic itself. Afterward, subjects were asked to rate tolerability of the drug on the Visual Analogue Scale (VAS). The VAS is a 100 mm horizontal line with verbal descriptors at either end. The VAS ratings were completed after the administration of the test medication. Subjects placed a single slash mark across the horizontal line between the end labeled "completely intolerable" (0 mm) and "easily tolerable" (100mm). | Missing data for one patient. | Count of Participants | Participants |
|
| Intraocular Pressure (IOP) | Median | Inter-Quartile Range | mmHg |
|
| OG001 | Vehicle | Drug vehicle eye drops four times a day for 8 weeks Vehicle: Drug vehicle eye drops four times a day for 8 weeks |
|
|
|
| Primary | The Change in the Ocular Surface Disease Index Score | Ocular Surface Disease Index (OSDI), a 12-item questionnaire, assesses symptom of ocular irritation in dry eye disease (DED) and how it affects functioning related to vision in the past week. It has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on 0 to 4 scale with 0 being "none of the time" and 4 being "all of the time." OSDI score range from 0-100 with score 0-12 being normal, 13-22 being mild DED, 23-32 being moderate DED, and >33 being severe DED. OSDI=[(sum of scores for questions answered)×100]/[(total questions answered)×4] | Posted | Median | Inter-Quartile Range | score on a scale | Between baseline and at 8 weeks of treatment |
|
|
|
|
| Other Pre-specified | The Change in Mucoid Debris Strands Between Baseline and 8-weeks | The presence of mucoid debris/strands over the ocular surface was assessed and the amount graded as the absence of mucoid debris (0) or presence of mucoid debris (1+, 2+ or 3+) with a bigger number indicating greater presence of mucoid debris with "3+" implying presence of the highest amount of mucoid debris and indicating the worst outcome. | Posted | Median | Inter-Quartile Range | score on a scale | Between baseline and 8-weeks of treatment |
|
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 9 |
| 25 |
| EG001 | Vehicle | Drug vehicle eye drops four times a day for 8 weeks Vehicle: Drug vehicle eye drops four times a day for 8 weeks | 0 | 22 | 0 | 22 | 12 | 21 |
| Blurred Vision | Eye disorders | Non-systematic Assessment |
|
| Burning | Eye disorders | Non-systematic Assessment |
|
| Light Sensitivity | Eye disorders | Non-systematic Assessment |
|
| Itching | Eye disorders | Non-systematic Assessment |
|
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Ocular GVHD |
|