A Phase 1/2 interventional study of DNase and Vehicle in Dry Eye, sponsored by University of Illinois at Chicago. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by University of Illinois at Chicago · Phase 1/2, Interventional, and Treatment
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 47 is below the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →University of Illinois at Chicago is the lead sponsor of 515 studies on the registry; 133 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
DNase 0.1% eye drops four times a day for 8 weeks
Drug: DNase
Drug vehicle eye drops four times a day for 8 weeks
Drug: Vehicle
DNase 0.1% eye drops four times a day for 8 weeks
Also known as: Pulmozyme
Drug vehicle eye drops four times a day for 8 weeks
Also known as: Placebo
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.
Time frame: 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=\[(sum of scores for questions answered)×100\]/\[(total questions answered)×4\]
Time frame: Between baseline and at 8 weeks of treatment
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.
Time frame: Between baseline and 8-weeks of treatment
This single-center study was conducted at the Department of Ophthalmology Clinical Trials and Translational Center, the University of Illinois at Chicago (UIC).
| Milestone | DNase | Vehicle |
|---|---|---|
| Started | 25 | 22 |
| Completed | 21 | 20 |
| Not completed | 4 | 2 |
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.
| score on a scale | DNase | Vehicle |
|---|---|---|
| OD | -1.00 (-3.00 to -1.00) | 0.00 (-0.25 to 1.00) |
| OS | -1.00 (-3.00 to -1.00) | 0.00 (0.00 to 1.00) |
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=\[(sum of scores for questions answered)×100\]/\[(total questions answered)×4\]
| score on a scale | DNase | Vehicle |
|---|---|---|
| OD | -20.75 (-37 to -11.80) | -8.43 (-25 to -0.7) |
| OS | -20.75 (-37 to -11.80) | -8.43 (-25 to -0.7) |
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.
| score on a scale | DNase | Vehicle |
|---|---|---|
| OD | -1.00 (-2.00 to 0.00) | 0.00 (0.00 to 1.00) |
| OS | 0.00 (-1.00 to 0.00) | 0.00 (0.00 to 0.25) |
Collected over Between baseline and 8-weeks of treatment.. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DNase | 0/25 (0%) | 0/25 (0%) | 9/25 (36%) |
| Vehicle | 0/22 (0%) | 0/22 (0%) | 12/21 (57.1%) |
| Event | DNase | Vehicle |
|---|---|---|
| BurningEye disorders | 5/25 | 2/21 |
| ItchingEye disorders | 1/25 | 4/21 |
| GrittinesEye disorders | 4/25 | 2/21 |
| Blurred VisionEye disorders | 3/25 | 3/21 |
| Light SensitivityEye disorders | 1/25 | 1/21 |
| Age, Continuous(Years) | DNase | Vehicle | Total |
|---|---|---|---|
| Median | 57 (44 to 64) | 55.5 (50.2 to 60.8) | 56 (47 to 62.5) |
| Sex: Female, Male(Participants) | DNase | Vehicle | Total |
|---|---|---|---|
| Female | 23 | 17 | 40 |
| Male | 2 | 5 | 7 |
| Ethnicity (NIH/OMB)(Participants) | DNase | Vehicle | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 5 | 15 |
| Not Hispanic or Latino | 15 | 17 | 32 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | DNase | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 5 | 5 | 10 |
| White | 18 | 15 | 33 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | DNase | Vehicle | Total |
|---|---|---|---|
| United States | 25 | 22 | 47 |
| Diagnosis(Participants) | DNase | Vehicle | Total |
|---|---|---|---|
| Sjogren's Syndrome | 13 | 12 | 25 |
| Non-Sjogren's DED | 8 | 6 | 14 |
| Ocular GVHD | 4 | 4 | 8 |
| OSDI(units on a scale) | DNase | Vehicle | Total |
|---|---|---|---|
| Median | 50 (32.5 to 62.5) | 49 (36.6 to 72.9) | 50 (33.65 to 71.335) |
| Corneal Staining(units on a scale) | DNase | Vehicle | Total |
|---|---|---|---|
| Oculus Dexter (OD) | 5 (3 to 7) | 5 (4 to 8) | 5 (3 to 6.25) |
| Oculus Sinister (OS) | 5 (3 to 6) | 5 (4 to 8) | 5 (4 to 7) |
7 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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University of Illinois at Chicago