A Phase 2/3 interventional study of Triesence and balanced salt solution BSS in Glaucoma, sponsored by Wills Eye. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2018-07-10.
Sponsored by Wills Eye · Phase 2/3, Interventional, and Treatment
The investigators hypothesize that intracameral Triesence during glaucoma surgery will provide lower intraocular pressure through better control of ocular inflammation, thus leading to a more successful filtering procedure.
Determine the efficacy and safety of intracameral Triesence in patients who undergo trabeculectomy, tube shunt, or combined cataract extraction, intra-ocular lens implantation and trabeculectomy with or without adjunctive mitomycin-C.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 77 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Wills Eye is the lead sponsor of 74 studies on the registry; 3 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
glaucoma surgery with 0.2cc Triesence adjunct.
Drug: Triesence
glaucoma surgery with balanced salt solution, the standard technique.
Drug: balanced salt solution BSS
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.
Also known as: triamcinolone acetonide injectable
At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure.
Also known as: balanced salt solution
Intraocular Pressure (IOP)
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
Anterior Chamber Inflammation (Flare)
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
Bleb Appearance
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
Patient Comfort
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
Ocular Hypotensive Medications
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
February 2009 to July 2011 at the Wills Eye Hospital
| Milestone | Treatment 1(Triesence) | Treatment 2 (Balanced Salt Solution BSS) |
|---|---|---|
| Started | 37 | 40 |
| Completed | 35 | 36 |
| Not completed | 2 | 4 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Never had surgery | 1 | 0 |
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.
| mm Hg | Treatment 1(Triesence) | Treatment 2 (Balanced Salt Solution BSS) |
|---|---|---|
| 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) |
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).
| photon counts per millisecond (p/msec) | Treatment 1(Triesence) | Treatment 2 (Balanced Salt Solution BSS) |
|---|---|---|
| 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) |
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.
| units on a scale | Triesence (Treatment 1) | Balanced Salt Solution (BSS Treatment 2) |
|---|---|---|
| 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) |
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.
| Patient comfort questionnaire score | Treatment 1(Triesence) | Treatment 2 (Balanced Salt Solution BSS) |
|---|---|---|
| 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) |
Number of ocular hypotensive ophthalmic solutions (eye drops) needed, if any, to maintain lower eye pressure.
| eye drops | Treatment 1(Triesence) | Treatment 2 (Balanced Salt Solution BSS) |
|---|---|---|
| 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) |
Collected over surgery, day 1, 1 week, 1 month, 3 month, 6 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment 1(Triesence) | 0/37 (0%) | 0/37 (0%) | 8/37 (21.6%) |
| Treatment 2 (Balanced Salt Solution BSS) | 0/40 (0%) | 0/40 (0%) | 10/40 (25%) |
| Event | Treatment 1(Triesence) | Treatment 2 (Balanced Salt Solution BSS) |
|---|---|---|
| IOP failureEye disorders | 7/37 | 8/40 |
| choroidals drained; A/C reformedEye disorders | 1/37 | 2/40 |
| Age, Continuous(years) | Treatment 1(Triesence) | Treatment 2 (Balanced Salt Solution BSS) | Total |
|---|---|---|---|
| Median | 68 (47 to 88) | 69 (42 to 88) | 68.5 (42 to 88) |
| Sex: Female, Male(Participants) | Treatment 1(Triesence) | Treatment 2 (Balanced Salt Solution BSS) | Total |
|---|---|---|---|
| Female | 20 | 17 | 37 |
| Male | 17 | 23 | 40 |
| Race (NIH/OMB)(Participants) | Treatment 1(Triesence) | Treatment 2 (Balanced Salt Solution BSS) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 16 | 23 | 39 |
| White | 17 | 15 | 32 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 1 | 5 |
| Region of Enrollment(participants) | Treatment 1(Triesence) | Treatment 2 (Balanced Salt Solution BSS) | Total |
|---|---|---|---|
| United States | 37 | 40 | 77 |
| Interocular Pressure (mmHg)(mmHg) | Treatment 1(Triesence) | Treatment 2 (Balanced Salt Solution BSS) | Total |
|---|---|---|---|
| Median | 24.5 (13 to 40) | 23.8 (8.5 to 56) | 24.0 (8.5 to 56) |
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