Trial Outcomes & Findings for Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery? (NCT NCT00853905)
NCT ID: NCT00853905
Last Updated: 2018-07-10
Results Overview
Intraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was \<21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
77 participants
Primary outcome timeframe
1 day, 1week, 1 month, 3 month and 6 month post-op visits
Results posted on
2018-07-10
Participant Flow
February 2009 to July 2011 at the Wills Eye Hospital
Participant milestones
| Measure |
Treatment 1(Triesence)
0.2cc Triesence
At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.
|
Treatment 2 (Balanced Salt Solution BSS)
glaucoma surgery with balanced salt solution, the standard technique.
At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
40
|
|
Overall Study
COMPLETED
|
35
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
Reasons for withdrawal
| Measure |
Treatment 1(Triesence)
0.2cc Triesence
At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.
|
Treatment 2 (Balanced Salt Solution BSS)
glaucoma surgery with balanced salt solution, the standard technique.
At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
never had surgery
|
1
|
0
|
Baseline Characteristics
Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?
Baseline characteristics by cohort
| Measure |
Treatment 1(Triesence)
n=37 Participants
0.2cc Triesence
Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound
|
Treatment 2 (Balanced Salt Solution BSS)
n=40 Participants
glaucoma surgery with balanced salt solution, the standard technique used.
balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure.
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=93 Participants
|
69 years
n=4 Participants
|
68.5 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
16 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
37 participants
n=93 Participants
|
40 participants
n=4 Participants
|
77 participants
n=27 Participants
|
|
Interocular Pressure (mmHg)
|
24.5 mmHg
n=93 Participants
|
23.8 mmHg
n=4 Participants
|
24.0 mmHg
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 day, 1week, 1 month, 3 month and 6 month post-op visitsIntraocular pressure (IOP) was measured by applanation tonometry in millimeters of mercury (mmHg). Surgical success was determined if IOP was \<21mmHg and 20% less than baseline IOP. Failure was defined as inability to meet criteria for success or IOP was less than 5mmHg.
Outcome measures
| Measure |
Treatment 1(Triesence)
n=37 Participants
0.2cc Triesence At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.
|
Treatment 2 (Balanced Salt Solution BSS)
n=40 Participants
balanced salt solution At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
|
|---|---|---|
|
Intraocular Pressure (IOP)
Day 1
|
16.1 mm Hg
Interval 13.1 to 19.05
|
12.8 mm Hg
Interval 10.7 to 15.0
|
|
Intraocular Pressure (IOP)
Week 1
|
11.7 mm Hg
Interval 9.1 to 14.5
|
11.8 mm Hg
Interval 9.8 to 13.9
|
|
Intraocular Pressure (IOP)
Month 1
|
16.1 mm Hg
Interval 13.0 to 19.4
|
14.4 mm Hg
Interval 12.2 to 16.8
|
|
Intraocular Pressure (IOP)
Month 3
|
15.1 mm Hg
Interval 12.2 to 18.4
|
12.8 mm Hg
Interval 10.7 to 15.1
|
|
Intraocular Pressure (IOP)
Month 6
|
14.6 mm Hg
Interval 11.7 to 17.8
|
13.6 mm Hg
Interval 11.5 to 16.0
|
SECONDARY outcome
Timeframe: 1 month, 3 month and 6 month post-op visitsInflammation in the anterior chamber (called flare), is measured 10 times per eye using the flare meter, a non-invasive measurement. Flare meter measures inflammation in photon counts per millisecond (p/msec).
Outcome measures
| Measure |
Treatment 1(Triesence)
n=37 Participants
0.2cc Triesence At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.
|
Treatment 2 (Balanced Salt Solution BSS)
n=40 Participants
balanced salt solution At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
|
|---|---|---|
|
Anterior Chamber Inflammation (Flare)
Month 1
|
0.4 photon counts per millisecond (p/msec)
Interval -0.2 to 0.8
|
1.0 photon counts per millisecond (p/msec)
Interval 0.6 to 1.4
|
|
Anterior Chamber Inflammation (Flare)
Month 3
|
0.6 photon counts per millisecond (p/msec)
Interval 0.0 to 1.1
|
0.4 photon counts per millisecond (p/msec)
Interval -0.1 to 0.9
|
|
Anterior Chamber Inflammation (Flare)
Month 6
|
0.3 photon counts per millisecond (p/msec)
Interval -0.2 to 0.8
|
0.2 photon counts per millisecond (p/msec)
Interval -0.2 to 0.7
|
SECONDARY outcome
Timeframe: 1 day, 1 week, 1 month, 3 month and 6 month post-op visitsPopulation: Bleb assessment by IBAGS was not obtained at all visits. Overall, 20 of 37 (Triesence) and 20 of 40 (BSS) blebs were measured.
A bleb is a blister on the white part of the eye (sclera) intentionally formed during some glaucoma surgeries. The Indiana Bleb Appearance Grading Scale (IBAGS) measures the bleb appearance in elevation (height), extent and vascularity. The height range is flat, low, moderate and high with 0 to 3 units on a scale. Zero is a flat bleb and 3 is a high bleb. Elevated functioning blebs increase the success of glaucoma surgery.
Outcome measures
| Measure |
Treatment 1(Triesence)
n=20 Participants
0.2cc Triesence At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.
|
Treatment 2 (Balanced Salt Solution BSS)
n=20 Participants
balanced salt solution At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
|
|---|---|---|
|
Bleb Appearance
Day 1
|
1.7 units on a scale
Interval 1.4 to 2.1
|
2.1 units on a scale
Interval 1.7 to 2.5
|
|
Bleb Appearance
Week 1
|
1.7 units on a scale
Interval 1.4 to 2.1
|
1.9 units on a scale
Interval 1.5 to 2.3
|
|
Bleb Appearance
Month 1
|
2.2 units on a scale
Interval 1.8 to 2.6
|
1.9 units on a scale
Interval 1.5 to 2.3
|
|
Bleb Appearance
Month 3
|
2.0 units on a scale
Interval 1.6 to 2.4
|
1.8 units on a scale
Interval 1.4 to 2.2
|
|
Bleb Appearance
Month 6
|
1.9 units on a scale
Interval 1.5 to 2.3
|
2.1 units on a scale
Interval 1.6 to 2.5
|
SECONDARY outcome
Timeframe: 1 day, 1 week, 1 month, 3 month and 6 month post-op visitsQuestionnaire administered to capture feeling of dry eye. Dry eye was graded on a scale of absent, mild, moderate and severe with 0 to 3 units on a scale.
Outcome measures
| Measure |
Treatment 1(Triesence)
n=37 Participants
0.2cc Triesence At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.
|
Treatment 2 (Balanced Salt Solution BSS)
n=40 Participants
balanced salt solution At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
|
|---|---|---|
|
Patient Comfort
Day 1
|
0.3 Patient comfort questionnaire score
Interval 0.1 to 0.6
|
0.1 Patient comfort questionnaire score
Interval -0.1 to 0.4
|
|
Patient Comfort
Week 1
|
0.6 Patient comfort questionnaire score
Interval 0.4 to 0.9
|
0.3 Patient comfort questionnaire score
Interval 0.0 to 0.5
|
|
Patient Comfort
Month 1
|
0.3 Patient comfort questionnaire score
Interval 0.0 to 0.5
|
0.6 Patient comfort questionnaire score
Interval 0.4 to 0.9
|
|
Patient Comfort
Month 3
|
0.4 Patient comfort questionnaire score
Interval 0.1 to 0.6
|
0.4 Patient comfort questionnaire score
Interval 0.2 to 0.7
|
|
Patient Comfort
Month 6
|
0.7 Patient comfort questionnaire score
Interval 0.4 to 0.9
|
0.7 Patient comfort questionnaire score
Interval 0.5 to 0.9
|
SECONDARY outcome
Timeframe: 1 week, 1 month, 3 month, and or 6 month post-op visitsNumber of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure.
Outcome measures
| Measure |
Treatment 1(Triesence)
n=37 Participants
0.2cc Triesence At end of standard glaucoma surgery and the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure, 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound.
|
Treatment 2 (Balanced Salt Solution BSS)
n=40 Participants
balanced salt solution At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
|
|---|---|---|
|
Ocular Hypotensive Medications
Week 1
|
0.03 eye drops
Interval 0.0 to 0.16
|
0.06 eye drops
Interval 0.02 to 0.2
|
|
Ocular Hypotensive Medications
Month 1
|
0.1 eye drops
Interval 0.04 to 0.26
|
0.03 eye drops
Interval 0.0 to 0.17
|
|
Ocular Hypotensive Medications
Month 3
|
0.08 eye drops
Interval 0.02 to 0.23
|
0.22 eye drops
Interval 0.11 to 0.41
|
|
Ocular Hypotensive Medications
Month 6
|
0.22 eye drops
Interval 0.11 to 0.39
|
0.22 eye drops
Interval 0.11 to 0.41
|
Adverse Events
Treatment 1(Triesence)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Treatment 2 (Balanced Salt Solution BSS)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment 1(Triesence)
n=37 participants at risk
0.2cc Triesence
Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound
|
Treatment 2 (Balanced Salt Solution BSS)
n=40 participants at risk
glaucoma surgery with balanced salt solution, the standard technique used.
balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure.
|
|---|---|---|
|
Eye disorders
IOP failure
|
18.9%
7/37 • Number of events 7 • surgery, day 1, 1 week, 1 month, 3 month, 6 month
|
20.0%
8/40 • Number of events 8 • surgery, day 1, 1 week, 1 month, 3 month, 6 month
|
|
Eye disorders
choroidals drained; A/C reformed
|
2.7%
1/37 • Number of events 1 • surgery, day 1, 1 week, 1 month, 3 month, 6 month
|
5.0%
2/40 • Number of events 2 • surgery, day 1, 1 week, 1 month, 3 month, 6 month
|
Additional Information
Marlene Moster MD
Wills Eye Hospital Glaucoma Research Center
Phone: 215-825-4713
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place