Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00853905 | Will the Use of Triesence During Glaucoma Surgery Provide Lower Eye Pressure and Improve the Results of the Surgery? | PHASE2 | COMPLETED | 77 | — | — | Feb 1, 2009 | Jan 1, 2012 | Jul 10, 2018 | 1 | United States |
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.
| Arm | Type | Description |
|---|---|---|
| Treatment 1(Triesence) | EXPERIMENTAL | glaucoma surgery with 0.2cc Triesence adjunct. |
| Treatment 2 (balanced salt solution BSS) | ACTIVE_COMPARATOR | glaucoma surgery with balanced salt solution, the standard technique. |
| Name | Type | Description |
|---|---|---|
| Triesence | DRUG | 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 | DRUG | At end of standard glaucoma surgery, the anterior chamber is reformed with balanced salt solution or viscoelastic to an adequate intraocular pressure. |
Inclusion Criteria: * glaucoma patients requiring surgery (Trabeculectomy or Express Shunt; Trabeculectomy plus Phacoemulsification and Interocular Lens Implant; Baerveldt Tube; Ahmed Tube; Molteno Tube) * primary open angle glaucoma * primary angle-closure glaucoma * pseudoexfoliation glaucoma * p...