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Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery?

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ClinicalTrials.gov Identifier: NCT00853905
Recruitment Status : Completed
First Posted : March 2, 2009
Results First Posted : March 21, 2016
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
Alcon Research
Information provided by (Responsible Party):
Marlene Moster, MD, Wills Eye

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Glaucoma
Interventions Drug: Triesence
Drug: balanced salt solution BSS
Enrollment 77
Recruitment Details February 2009 to July 2011 at the Wills Eye Hospital
Pre-assignment Details  
Arm/Group Title Treatment 1(Triesence) Treatment 2 (Balanced Salt Solution BSS)
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 37 40
Completed 35 36
Not Completed 2 4
Reason Not Completed
Lost to Follow-up             1             3
Withdrawal by Subject             0             1
never had surgery             1             0
Arm/Group Title Treatment 1(Triesence) Treatment 2 (Balanced Salt Solution BSS) Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 37 40 77
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 37 participants 40 participants 77 participants
68
(47 to 88)
69
(42 to 88)
68.5
(42 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 40 participants 77 participants
Female
20
  54.1%
17
  42.5%
37
  48.1%
Male
17
  45.9%
23
  57.5%
40
  51.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants 40 participants 77 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   2.5%
1
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
16
  43.2%
23
  57.5%
39
  50.6%
White
17
  45.9%
15
  37.5%
32
  41.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
  10.8%
1
   2.5%
5
   6.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants 40 participants 77 participants
37 40 77
Interocular Pressure (mmHg)  
Median (Full Range)
Unit of measure:  mmHg
Number Analyzed 37 participants 40 participants 77 participants
24.5
(13 to 40)
23.8
(8.5 to 56)
24.0
(8.5 to 56)
1.Primary Outcome
Title Intraocular Pressure (IOP)
Hide Description 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.
Time Frame 1 day, 1week, 1 month, 3 month and 6 month post-op visits
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment 1(Triesence) Treatment 2 (Balanced Salt Solution BSS)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 37 40
Mean (95% Confidence Interval)
Unit of Measure: mm Hg
Day 1
16.1
(13.1 to 19.05)
12.8
(10.7 to 15.0)
Week 1
11.7
(9.1 to 14.5)
11.8
(9.8 to 13.9)
Month 1
16.1
(13.0 to 19.4)
14.4
(12.2 to 16.8)
Month 3
15.1
(12.2 to 18.4)
12.8
(10.7 to 15.1)
Month 6
14.6
(11.7 to 17.8)
13.6
(11.5 to 16.0)
2.Secondary Outcome
Title Anterior Chamber Inflammation (Flare)
Hide Description Inflammation 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).
Time Frame 1 month, 3 month and 6 month post-op visits
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment 1(Triesence) Treatment 2 (Balanced Salt Solution BSS)
Hide Arm/Group Description:
0.2cc Triesence At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
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.
Overall Number of Participants Analyzed 37 40
Mean (95% Confidence Interval)
Unit of Measure: photon counts per millisecond (p/msec)
Month 1
0.4
(-0.2 to 0.8)
1.0
(0.6 to 1.4)
Month 3
0.6
(0 to 1.1)
0.4
(-0.1 to 0.9)
Month 6
0.3
(-0.2 to 0.8)
0.2
(-0.2 to 0.7)
3.Secondary Outcome
Title Bleb Appearance
Hide Description 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.
Time Frame 1 day, 1 week, 1 month, 3 month and 6 month post-op visits
Hide Outcome Measure Data
Hide Analysis Population Description
Bleb assessment by IBAGS was not obtained at all visits. Overall, 20 of 37 (Triesence) and 20 of 40 (BSS) blebs were measured.
Arm/Group Title Triesence (Treatment 1) Balanced Salt Solution (BSS Treatment 2)
Hide Arm/Group Description:
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.
balanced salt solution (BSS) At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
Overall Number of Participants Analyzed 20 20
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
Day 1
1.7
(1.4 to 2.1)
2.1
(1.7 to 2.5)
Week 1
1.7
(1.4 to 2.1)
1.9
(1.5 to 2.3)
Month 1
2.2
(1.8 to 2.6)
1.9
(1.5 to 2.3)
Month 3
2.0
(1.6 to 2.4)
1.8
(1.4 to 2.2)
Month 6
1.9
(1.5 to 2.3)
2.1
(1.6 to 2.5)
4.Secondary Outcome
Title Patient Comfort
Hide Description Questionnaire 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.
Time Frame 1 day, 1 week, 1 month, 3 month and 6 month post-op visits
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment 1(Triesence) Treatment 2 (Balanced Salt Solution BSS)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 37 40
Mean (95% Confidence Interval)
Unit of Measure: Patient comfort questionnaire score
Day 1
0.3
(0.1 to 0.6)
0.1
(-0.1 to 0.4)
Week 1
0.6
(0.4 to 0.9)
0.3
(0 to 0.5)
Month 1
0.3
(0 to 0.5)
0.6
(0.4 to 0.9)
Month 3
0.4
(0.1 to 0.6)
0.4
(0.2 to 0.7)
Month 6
0.7
(0.4 to 0.9)
0.7
(0.5 to 0.9)
5.Secondary Outcome
Title Ocular Hypotensive Medications
Hide Description Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure.
Time Frame 1 week, 1 month, 3 month, and or 6 month post-op visits
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Treatment 1(Triesence) Treatment 2 (Balanced Salt Solution BSS)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 37 40
Mean (95% Confidence Interval)
Unit of Measure: eye drops
Week 1
0.03
(0.0 to 0.16)
0.06
(0.02 to 0.2)
Month 1
0.1
(0.04 to 0.26)
0.03
(0 to 0.17)
Month 3
0.08
(0.02 to 0.23)
0.22
(0.11 to 0.41)
Month 6
0.22
(0.11 to 0.39)
0.22
(0.11 to 0.41)
Time Frame surgery, day 1, 1 week, 1 month, 3 month, 6 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment 1(Triesence) Treatment 2 (Balanced Salt Solution BSS)
Hide Arm/Group Description

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

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.

All-Cause Mortality
Treatment 1(Triesence) Treatment 2 (Balanced Salt Solution BSS)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/37 (0.00%)      0/40 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment 1(Triesence) Treatment 2 (Balanced Salt Solution BSS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/37 (0.00%)      0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment 1(Triesence) Treatment 2 (Balanced Salt Solution BSS)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/37 (21.62%)      10/40 (25.00%)    
Eye disorders     
IOP failure * [1]  7/37 (18.92%)  7 8/40 (20.00%)  8
choroidals drained; A/C reformed * [2]  1/37 (2.70%)  1 2/40 (5.00%)  2
*
Indicates events were collected by non-systematic assessment
[1]
IOP failed to drop 20% or less than a 5mmhg drop from original IOP; eye drops added
[2]
patient needed another glaucoma procedure
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marlene Moster MD
Organization: Wills Eye Hospital Glaucoma Research Center
Phone: 215-825-4713
EMail: jmolineaux@willseye.org
Layout table for additonal information
Responsible Party: Marlene Moster, MD, Wills Eye
ClinicalTrials.gov Identifier: NCT00853905     History of Changes
Other Study ID Numbers: 07-827
First Submitted: February 27, 2009
First Posted: March 2, 2009
Results First Submitted: February 12, 2015
Results First Posted: March 21, 2016
Last Update Posted: July 10, 2018