Trial Outcomes & Findings for Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma (NCT NCT02338362)
NCT ID: NCT02338362
Last Updated: 2019-05-03
Results Overview
Masked assessment of intraocular pressure using goldmann application tonometry. Mean of 2 measurements within 1 mmHg will be recorded.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
22 participants
Primary outcome timeframe
week 6
Results posted on
2019-05-03
Participant Flow
1,960 records of glaucoma patients with scheduled visits in a university-based glaucoma clinic were screened between August 1, 2014 and November 7, 2014.
22 consented to participate and 20 completed the study.
Participant milestones
| Measure |
Steroid Inhaler
randomized to 6 weeks of 1 puff twice daily 250ug fluticasone propionate inhaled.
|
Placebo Inhaler
randomized to 6 weeks of 1 puff twice daily saline inhaled.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Steroid Inhaler
randomized to 6 weeks of 1 puff twice daily 250ug fluticasone propionate inhaled.
|
Placebo Inhaler
randomized to 6 weeks of 1 puff twice daily saline inhaled.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma
Baseline characteristics by cohort
| Measure |
Fluticasone
n=10 Participants
participants will be asked to use fluticasone propionate 250 µg metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
Saline Placebo
n=10 Participants
participants will be asked to use a saline placebo metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.7 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
65.7 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
65.7 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Mean intraocular pressure
|
14.3 mmHg
STANDARD_DEVIATION 3.0 • n=5 Participants
|
15.6 mmHg
STANDARD_DEVIATION 3.6 • n=7 Participants
|
15.0 mmHg
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Mean number of ocular hypotensive medications
|
1.3 medication classes
STANDARD_DEVIATION 0.7 • n=5 Participants
|
1.3 medication classes
STANDARD_DEVIATION 1.4 • n=7 Participants
|
1.3 medication classes
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Prior laser trabeculoplasty
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Mean central corneal thickness
|
553.1 micrometers
STANDARD_DEVIATION 31.7 • n=5 Participants
|
549.1 micrometers
STANDARD_DEVIATION 30.8 • n=7 Participants
|
551.1 micrometers
STANDARD_DEVIATION 31.25 • n=5 Participants
|
|
Mean cup-disc ratio
|
0.49 cup:disc ratio
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.38 cup:disc ratio
STANDARD_DEVIATION 0.2 • n=7 Participants
|
0.44 cup:disc ratio
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Mean visual field mean deviation
|
-0.72 decibels (dB)
STANDARD_DEVIATION 2.6 • n=5 Participants
|
-1.13 decibels (dB)
STANDARD_DEVIATION 2.5 • n=7 Participants
|
-0.92 decibels (dB)
STANDARD_DEVIATION 2.6 • n=5 Participants
|
|
Mean logMAR visual acuity
|
0.19 logMAR
STANDARD_DEVIATION 0.1 • n=5 Participants
|
0.18 logMAR
STANDARD_DEVIATION 0.1 • n=7 Participants
|
0.18 logMAR
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Diagnosis
Ocular Hypertension
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Diagnosis
Primary Open-Angle Glaucoma
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Diagnosis
Pigment Dispersion Glaucoma
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Diagnosis
Pseudoexfoliative Glaucoma
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: week 6Masked assessment of intraocular pressure using goldmann application tonometry. Mean of 2 measurements within 1 mmHg will be recorded.
Outcome measures
| Measure |
Fluticasone
n=10 Participants
participants will be asked to use fluticasone propionate 250 µg metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
Saline Placebo
n=10 Participants
participants will be asked to use a saline placebo metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
|---|---|---|
|
Mean Intraocular Pressure
|
14.7 mmHg
Standard Deviation 2.4
|
14.8 mmHg
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: week 6best corrected logMAR visual acuity for each eye. 20/20 vision corresponds with a logMAR score of 0, while negative logMAR scores indicate better than 20/20 vision, values \> 0.5 correspond with low vision, and values \> 1.3 correspond with blindness.
Outcome measures
| Measure |
Fluticasone
n=10 Participants
participants will be asked to use fluticasone propionate 250 µg metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
Saline Placebo
n=10 Participants
participants will be asked to use a saline placebo metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
|---|---|---|
|
Mean Visual Acuity
|
0.15 logMAR
Standard Deviation 0.12
|
0.15 logMAR
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: from baseline to week 6subjective (reported) and objective (slit lamp examination) side-effects attributable to study medications
Outcome measures
| Measure |
Fluticasone
n=10 Participants
participants will be asked to use fluticasone propionate 250 µg metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
Saline Placebo
n=10 Participants
participants will be asked to use a saline placebo metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
|---|---|---|
|
Side Effects
lens opacity
|
0 participants
|
0 participants
|
|
Side Effects
throat discomfort
|
1 participants
|
1 participants
|
|
Side Effects
headache
|
1 participants
|
0 participants
|
|
Side Effects
difficulty sleeping
|
0 participants
|
1 participants
|
|
Side Effects
no adverse effects
|
8 participants
|
8 participants
|
SECONDARY outcome
Timeframe: within 6-week observation periodParticipants with 2 consecutive intraocular pressure measurements exceeding 20% increase from baseline were discontinued from study.
Outcome measures
| Measure |
Fluticasone
n=10 Participants
participants will be asked to use fluticasone propionate 250 µg metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
Saline Placebo
n=10 Participants
participants will be asked to use a saline placebo metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
|---|---|---|
|
Intraocular Pressure Elevation >20% From Baseline
elevation >20%
|
1 participants
|
0 participants
|
|
Intraocular Pressure Elevation >20% From Baseline
no elevation >20%
|
9 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Completion of study, up to 6 weeksAdherence was calculated from self-reported study diaries and correlated to a counter that measured number of inhaled puffs built into the placebo metered-dose inhalers
Outcome measures
| Measure |
Fluticasone
n=10 Participants
participants will be asked to use fluticasone propionate 250 µg metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
Saline Placebo
n=10 Participants
participants will be asked to use a saline placebo metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
|---|---|---|
|
Adherence
|
93.6 percentage of required doses
Standard Deviation 7.1
|
96.1 percentage of required doses
Standard Deviation 4.4
|
Adverse Events
Fluticasone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Saline Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluticasone
n=10 participants at risk
participants will be asked to use fluticasone propionate 250 µg metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
Saline Placebo
n=10 participants at risk
participants will be asked to use a saline placebo metered-dose inhaler 1 puff twice-daily for 6 weeks.
|
|---|---|---|
|
General disorders
sore throat
|
10.0%
1/10 • Number of events 1 • 6 weeks of study
Patients were asked about any side-effects they were experiencing at each biweekly study visit.
|
10.0%
1/10 • Number of events 1 • 6 weeks of study
Patients were asked about any side-effects they were experiencing at each biweekly study visit.
|
|
General disorders
headache
|
10.0%
1/10 • Number of events 1 • 6 weeks of study
Patients were asked about any side-effects they were experiencing at each biweekly study visit.
|
0.00%
0/10 • 6 weeks of study
Patients were asked about any side-effects they were experiencing at each biweekly study visit.
|
|
General disorders
difficulty sleeping
|
0.00%
0/10 • 6 weeks of study
Patients were asked about any side-effects they were experiencing at each biweekly study visit.
|
10.0%
1/10 • Number of events 1 • 6 weeks of study
Patients were asked about any side-effects they were experiencing at each biweekly study visit.
|
Additional Information
Dr. Graham Trope
Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada
Phone: 1-416-603-5117
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place