Trial · NCT02193490
DNase Treatment for Dry Eyes
NCT02193490, Phase 1, Phase 2, Terminated, University of Illinois Chicago; results first posted 2019-11-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. DNase Treatment for Dry Eyes. Trials, record NCT02193490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02193490
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- DNase Treatment for Dry Eyes
- NCT number
- NCT02193490
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- University of Illinois Chicago
- Conditions
- Dry Eye
- Interventions
- DNase, Vehicle
- First posted
- 2014-07-17
- Last updated
- 2020-01-18
- Results first posted
- 2019-11-05
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining | Between baseline and at 8 weeks of treatment | 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. |
| Primary | The Change in the Ocular Surface Disease Index Score | Between baseline and at 8 weeks of treatment | 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=\[(sum of scores for questions answered)×100\]/\[(total questions answered)×4\] |
| Other | The Change in Mucoid Debris Strands Between Baseline and 8-weeks | Between baseline and 8-weeks of treatment | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining | Between baseline and at 8 weeks of treatment | score on a scale | MEDIAN | |
| PRIMARY | The Change in the Ocular Surface Disease Index Score | Between baseline and at 8 weeks of treatment | score on a scale | MEDIAN | |
| OTHER_PRE_SPECIFIED | The Change in Mucoid Debris Strands Between Baseline and 8-weeks | Between baseline and 8-weeks of treatment | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining | DNase | OD | -1.00 | Inter-Quartile Range -3.00 to -1.00 | score on a scale |
| The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining | Vehicle | OD | 0.00 | Inter-Quartile Range -0.25 to 1.00 | score on a scale |
| The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining | DNase | OS | -1.00 | Inter-Quartile Range -3.00 to -1.00 | score on a scale |
| The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining | Vehicle | OS | 0.00 | Inter-Quartile Range 0.00 to 1.00 | score on a scale |
| The Change in the Ocular Surface Disease Index Score | DNase | OD | -20.75 | Inter-Quartile Range -37 to -11.80 | score on a scale |
| The Change in the Ocular Surface Disease Index Score | Vehicle | OD | -8.43 | Inter-Quartile Range -25 to -0.7 | score on a scale |
| The Change in the Ocular Surface Disease Index Score | DNase | OS | -20.75 | Inter-Quartile Range -37 to -11.80 | score on a scale |
| The Change in the Ocular Surface Disease Index Score | Vehicle | OS | -8.43 | Inter-Quartile Range -25 to -0.7 | score on a scale |
| The Change in Mucoid Debris Strands Between Baseline and 8-weeks | DNase | OD | -1.00 | Inter-Quartile Range -2.00 to 0.00 | score on a scale |
| The Change in Mucoid Debris Strands Between Baseline and 8-weeks | Vehicle | OD | 0.00 | Inter-Quartile Range 0.00 to 1.00 | score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | DNase | 25 | |
| Overall Study | STARTED | Vehicle | 22 | |
| Overall Study | COMPLETED | DNase | 21 | |
| Overall Study | COMPLETED | Vehicle | 20 | |
| Overall Study | NOT COMPLETED | DNase | 4 | |
| Overall Study | NOT COMPLETED | Vehicle | 2 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Grittines | Eye disorders | DNase | 4 | 25 | |
| other | Grittines | Eye disorders | Vehicle | 2 | 21 | |
| other | Blurred Vision | Eye disorders | DNase | 3 | 25 | |
| other | Blurred Vision | Eye disorders | Vehicle | 3 | 21 | |
| other | Burning | Eye disorders | DNase | 5 | 25 | |
| other | Burning | Eye disorders | Vehicle | 2 | 21 | |
| other | Light Sensitivity | Eye disorders | DNase | 1 | 25 | |
| other | Light Sensitivity | Eye disorders | Vehicle | 1 | 21 | |
| other | Itching | Eye disorders | DNase | 1 | 25 | |
| other | Itching | Eye disorders | Vehicle | 4 | 21 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DNase | 0 | 25 |
| Total, all-cause mortality | Vehicle | 0 | 22 |
| Total, other adverse events | DNase | 9 | 25 |
| Total, other adverse events | Vehicle | 12 | 21 |
| Total, serious adverse events | DNase | 0 | 25 |
| Total, serious adverse events | Vehicle | 0 | 22 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| DNase vs Vehicle: deaths from any cause | Trial comparisons |
| DNase vs Vehicle: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02193490
GET https://conductscience.org/api/trials/v1/NCT02193490/registered