Trial Outcomes & Findings for Chalazion Conservative Treatment Trial (NCT NCT01230593)
NCT ID: NCT01230593
Last Updated: 2018-06-12
Results Overview
Defined as number of patients with chalazion size regression of 100%
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
4-6 weeks
Results posted on
2018-06-12
Participant Flow
Participant milestones
| Measure |
Hot Compress
Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.
Hot Compresses: Hot compresses 3x/day to eyelids
|
Hot Compress + Tobramycin Drops and Ointment
In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.
Tobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed.
|
Hot Compress + Tobramycin/Dexamethasone Drops and Ointment
In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.
Tobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
35
|
32
|
38
|
|
Overall Study
NOT COMPLETED
|
15
|
18
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chalazion Conservative Treatment Trial
Baseline characteristics by cohort
| Measure |
Hot Compress
n=50 Participants
Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.
Hot Compresses: Hot compresses 3x/day to eyelids
|
Hot Compress + Tobramycin Drops and Ointment
n=50 Participants
In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.
Tobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed.
|
Hot Compress + Tobramycin/Dexamethasone Drops and Ointment
n=49 Participants
In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.
Tobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
45.50 years
STANDARD_DEVIATION 15 • n=5 Participants
|
46.42 years
STANDARD_DEVIATION 19 • n=7 Participants
|
47.52 years
STANDARD_DEVIATION 17 • n=5 Participants
|
47.41 years
STANDARD_DEVIATION 17 • n=4 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
79 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
70 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
27 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
45 participants
n=7 Participants
|
35 participants
n=5 Participants
|
122 participants
n=4 Participants
|
|
Pre-treatment lesion duration (months)
|
3.55 months
STANDARD_DEVIATION 6 • n=5 Participants
|
2.88 months
STANDARD_DEVIATION 3 • n=7 Participants
|
5.72 months
STANDARD_DEVIATION 13 • n=5 Participants
|
3.96 months
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Initial lesion size (mm)
|
6.05 millimeters
STANDARD_DEVIATION 3 • n=5 Participants
|
6.16 millimeters
STANDARD_DEVIATION 3 • n=7 Participants
|
6.38 millimeters
STANDARD_DEVIATION 3 • n=5 Participants
|
6.19 millimeters
STANDARD_DEVIATION 3 • n=4 Participants
|
PRIMARY outcome
Timeframe: 4-6 weeksPopulation: Intention to treat population
Defined as number of patients with chalazion size regression of 100%
Outcome measures
| Measure |
Hot Compress
n=50 Participants
Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.
Hot Compresses: Hot compresses 3x/day to eyelids
|
Hot Compress + Tobramycin Drops and Ointment
n=50 Participants
In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.
Tobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed.
|
Hot Compress + Tobramycin/Dexamethasone Drops and Ointment
n=49 Participants
In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.
Tobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed.
|
|---|---|---|---|
|
Number of Participants With Complete Resolution
|
13 participants
|
12 participants
|
11 participants
|
SECONDARY outcome
Timeframe: baseline and 4-6 weeksPopulation: Intention to treat population
Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment
Outcome measures
| Measure |
Hot Compress
n=50 Participants
Patients in the hot compress arm will be shown how to apply hot compresses to the affected lid and gently massage the lid to encourage the chalazion to spontaneously drain for 5 minutes, 3x/day.
Hot Compresses: Hot compresses 3x/day to eyelids
|
Hot Compress + Tobramycin Drops and Ointment
n=50 Participants
In addition to using hot compress, patients in the Tobramycin arm will be prescribed Tobramycin drops 3x/day and ointment to be applied before bedtime.
Tobramycin Drops and Ointment: Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed.
|
Hot Compress + Tobramycin/Dexamethasone Drops and Ointment
n=49 Participants
In addition to using hot compress, patients in the Tobramycin/Dexamethasone arm will be prescribed Tobramycin/Dexamethasone drops 3x/day and ointment to be applied before bedtime.
Tobramycin/Dexamethasone Drops and Ointment: Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed.
|
|---|---|---|---|
|
Chalazion Size Difference Post-Treatment
|
1.20 millimeters
Standard Deviation 3
|
1.69 millimeters
Standard Deviation 3
|
1.54 millimeters
Standard Deviation 3
|
Adverse Events
Hot Compress
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hot Compress, Tobrex Drops, Tobrex Ointment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hot Compress, Tobradex Drops, Tobradex Ointment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place