Trial Outcomes & Findings for DNase Treatment for Dry Eyes (NCT NCT02193490)
NCT ID: NCT02193490
Last Updated: 2020-01-18
Results Overview
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.
TERMINATED
PHASE1/PHASE2
47 participants
Between baseline and at 8 weeks of treatment
2020-01-18
Participant Flow
This single-center study was conducted at the Department of Ophthalmology Clinical Trials and Translational Center, the University of Illinois at Chicago (UIC).
A 2-week washout period was required if topical corticosteroids or topical cyclosporine were discontinued before enrollment.
Participant milestones
| Measure |
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
|
Vehicle
Drug vehicle eye drops four times a day for 8 weeks
Vehicle: Drug vehicle eye drops four times a day for 8 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
22
|
|
Overall Study
COMPLETED
|
21
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Missing data for one patient.
Baseline characteristics by cohort
| Measure |
DNase
n=25 Participants
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
|
Vehicle
n=22 Participants
Drug vehicle eye drops four times a day for 8 weeks
Vehicle: Drug vehicle eye drops four times a day for 8 weeks
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 Years
n=25 Participants
|
55.5 Years
n=22 Participants
|
56 Years
n=47 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=25 Participants
|
17 Participants
n=22 Participants
|
40 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=25 Participants
|
5 Participants
n=22 Participants
|
7 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=25 Participants
|
5 Participants
n=22 Participants
|
15 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=25 Participants
|
17 Participants
n=22 Participants
|
32 Participants
n=47 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=25 Participants
|
1 Participants
n=22 Participants
|
3 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=25 Participants
|
5 Participants
n=22 Participants
|
10 Participants
n=47 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=25 Participants
|
15 Participants
n=22 Participants
|
33 Participants
n=47 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=47 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=25 Participants
|
22 participants
n=22 Participants
|
47 participants
n=47 Participants
|
|
Diagnosis
Sjogren's Syndrome
|
13 Participants
n=25 Participants
|
12 Participants
n=22 Participants
|
25 Participants
n=47 Participants
|
|
Diagnosis
Non-Sjogren's DED
|
8 Participants
n=25 Participants
|
6 Participants
n=22 Participants
|
14 Participants
n=47 Participants
|
|
Diagnosis
Ocular GVHD
|
4 Participants
n=25 Participants
|
4 Participants
n=22 Participants
|
8 Participants
n=47 Participants
|
|
OSDI
|
50 units on a scale
n=25 Participants
|
49 units on a scale
n=22 Participants
|
50 units on a scale
n=47 Participants
|
|
Corneal Staining
Oculus Dexter (OD)
|
5 units on a scale
n=25 Participants
|
5 units on a scale
n=22 Participants
|
5 units on a scale
n=47 Participants
|
|
Corneal Staining
Oculus Sinister (OS)
|
5 units on a scale
n=25 Participants
|
5 units on a scale
n=22 Participants
|
5 units on a scale
n=47 Participants
|
|
Mucoid Debris Strands
OD
|
20 Participants
n=25 Participants
|
17 Participants
n=22 Participants
|
37 Participants
n=47 Participants
|
|
Mucoid Debris Strands
OS
|
16 Participants
n=25 Participants
|
19 Participants
n=22 Participants
|
35 Participants
n=47 Participants
|
|
Schirmer I
OD
|
2 mm
n=25 Participants
|
0.75 mm
n=22 Participants
|
1 mm
n=47 Participants
|
|
Schirmer I
OS
|
2 mm
n=25 Participants
|
0.25 mm
n=22 Participants
|
1 mm
n=47 Participants
|
|
Conjunctival Staining
OD
|
4.00 units on a scale
n=25 Participants
|
4.00 units on a scale
n=22 Participants
|
4 units on a scale
n=47 Participants
|
|
Conjunctival Staining
OS
|
4.00 units on a scale
n=25 Participants
|
4.00 units on a scale
n=22 Participants
|
4 units on a scale
n=47 Participants
|
|
Conjunctival Injection
Temporal OD
|
40 units on a scale
n=25 Participants
|
45 units on a scale
n=22 Participants
|
40 units on a scale
n=47 Participants
|
|
Conjunctival Injection
Temporal OS
|
40 units on a scale
n=25 Participants
|
45 units on a scale
n=22 Participants
|
40 units on a scale
n=47 Participants
|
|
Conjunctival Injection
Nasal OD
|
40 units on a scale
n=25 Participants
|
40 units on a scale
n=22 Participants
|
40 units on a scale
n=47 Participants
|
|
Conjunctival Injection
Nasal OS
|
40 units on a scale
n=25 Participants
|
45 units on a scale
n=22 Participants
|
40 units on a scale
n=47 Participants
|
|
Corneal Filaments
OD
|
0 Participants
n=25 Participants
|
4 Participants
n=22 Participants
|
4 Participants
n=47 Participants
|
|
Corneal Filaments
OS
|
1 Participants
n=25 Participants
|
2 Participants
n=22 Participants
|
3 Participants
n=47 Participants
|
|
Tolerability [Oculus Uterque (OU)]
Tolerability (90)
|
2 Participants
n=25 Participants • Missing data for one patient.
|
0 Participants
n=21 Participants • Missing data for one patient.
|
2 Participants
n=46 Participants • Missing data for one patient.
|
|
Tolerability [Oculus Uterque (OU)]
Tolerability (100)
|
23 Participants
n=25 Participants • Missing data for one patient.
|
21 Participants
n=21 Participants • Missing data for one patient.
|
44 Participants
n=46 Participants • Missing data for one patient.
|
|
Intraocular Pressure (IOP)
OD
|
17.5 mmHg
n=25 Participants
|
18 mmHg
n=22 Participants
|
18 mmHg
n=47 Participants
|
|
Intraocular Pressure (IOP)
OS
|
18.5 mmHg
n=25 Participants
|
18 mmHg
n=22 Participants
|
18 mmHg
n=47 Participants
|
PRIMARY outcome
Timeframe: Between baseline and at 8 weeks of treatmentCorneal 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.
Outcome measures
| Measure |
DNase
n=21 Participants
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
|
Vehicle
n=20 Participants
Drug vehicle eye drops four times a day for 8 weeks
Vehicle: Drug vehicle eye drops four times a day for 8 weeks
|
|---|---|---|
|
The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining
OD
|
-1.00 score on a scale
Interval -3.0 to -1.0
|
0.00 score on a scale
Interval -0.25 to 1.0
|
|
The Change in Corneal Surface Staining as Measured by Rose Bengal Dye Staining
OS
|
-1.00 score on a scale
Interval -3.0 to -1.0
|
0.00 score on a scale
Interval 0.0 to 1.0
|
PRIMARY outcome
Timeframe: Between baseline and at 8 weeks of treatmentOcular 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=\[(sum of scores for questions answered)×100\]/\[(total questions answered)×4\]
Outcome measures
| Measure |
DNase
n=21 Participants
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
|
Vehicle
n=20 Participants
Drug vehicle eye drops four times a day for 8 weeks
Vehicle: Drug vehicle eye drops four times a day for 8 weeks
|
|---|---|---|
|
The Change in the Ocular Surface Disease Index Score
OD
|
-20.75 score on a scale
Interval -37.0 to -11.8
|
-8.43 score on a scale
Interval -25.0 to -0.7
|
|
The Change in the Ocular Surface Disease Index Score
OS
|
-20.75 score on a scale
Interval -37.0 to -11.8
|
-8.43 score on a scale
Interval -25.0 to -0.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Between baseline and 8-weeks of treatmentThe 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.
Outcome measures
| Measure |
DNase
n=21 Participants
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
|
Vehicle
n=20 Participants
Drug vehicle eye drops four times a day for 8 weeks
Vehicle: Drug vehicle eye drops four times a day for 8 weeks
|
|---|---|---|
|
The Change in Mucoid Debris Strands Between Baseline and 8-weeks
OD
|
-1.00 score on a scale
Interval -2.0 to 0.0
|
0.00 score on a scale
Interval 0.0 to 1.0
|
|
The Change in Mucoid Debris Strands Between Baseline and 8-weeks
OS
|
0.00 score on a scale
Interval -1.0 to 0.0
|
0.00 score on a scale
Interval 0.0 to 0.25
|
Adverse Events
DNase
Vehicle
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
DNase
n=25 participants at risk
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
|
Vehicle
n=21 participants at risk；n=22 participants at risk
Drug vehicle eye drops four times a day for 8 weeks
Vehicle: Drug vehicle eye drops four times a day for 8 weeks
|
|---|---|---|
|
Eye disorders
Grittines
|
16.0%
4/25 • Between baseline and 8-weeks of treatment.
|
9.5%
2/21 • Between baseline and 8-weeks of treatment.
|
|
Eye disorders
Blurred Vision
|
12.0%
3/25 • Between baseline and 8-weeks of treatment.
|
14.3%
3/21 • Between baseline and 8-weeks of treatment.
|
|
Eye disorders
Burning
|
20.0%
5/25 • Between baseline and 8-weeks of treatment.
|
9.5%
2/21 • Between baseline and 8-weeks of treatment.
|
|
Eye disorders
Light Sensitivity
|
4.0%
1/25 • Between baseline and 8-weeks of treatment.
|
4.8%
1/21 • Between baseline and 8-weeks of treatment.
|
|
Eye disorders
Itching
|
4.0%
1/25 • Between baseline and 8-weeks of treatment.
|
19.0%
4/21 • Between baseline and 8-weeks of treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place