Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT07276802
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The TRIBECA Study (TRIessence/Byqlovi for Easier CAtaract Surgery)
Sponsor:
Research Insight LLC
Organization:
Study Overview
Official Title:
The TRIBECA Study (TRIessence/Byqlovi for Easier CAtaract Surgery)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIBECA
Brief Summary:
A self-controlled, prospective clinical study of the safety, clinical efficacy, and patient acceptance of subconjunctival delivery of triamcinolone 40 mg/mL (Triesence) at the conclusion of cataract surgery or topical clobetasol 0.05 (Byqlovi) BID for 14 days, with intracameral moxifloxacin 0.5%, and topical nepafenac 0.3% (Ilevro) for 14 days, as compared to traditional topical postoperative prednisolone acetate 1% QID, moxifloxacin 0.5% drops QID, and ketorolac 0.5% QID in controlling postoperative pain and inflammation in subjects undergoing sequential bilateral cataract surgery.
Detailed Description:
Drug delivery is one of the most exciting advances in ophthalmology, and with new products available comes the opportunity for an improved patient experience in cataract surgery. Frequent use of topical medications is associated with difficulty in application and compliance for many patients and create a burden for family members. In addition there is a cost to many patients that presents financial obstacles.
The purpose of this study is to evaluate the safety, effectiveness and patient acceptance of two post cataract surgery drug treatment regimens that minimize the use of topical medications. This will be a prospective evaluation of patients having routine, bilateral cataract surgery in which one eye of each subject will be randomized to receive a "conventional" regimen and the other eye will receive a regimen of "less drops". The "less drops" regimen will include EITHER (by randomization) a 0.1 cc subconjunctival injection of triamcinolone 40mg/mL (Triesence) at the end of surgery OR postoperative administration of topical clobetasol 0.05% (Byqlovi) BID for 14 days to deliver corticosteroid. Both steroid regimens will be delivered with nepafenac 0.3% QD for 14 days as a topical NSAID, and intracameral moxifloxacin 0.5% QID for 7 days as an antibiotic. The "conventional" topical medication regimen will include prednisolone acetate 1% QID, ketorolac 0.5% QID , and moxifloxacin 0.5% topical drops QID. With all of these treatment regimens, the patients will be receiving two on-label, FDA approved products and one (intracameral moxifloxacin) that is technically off-label but is so well accepted that it is used in approximately half the cataract surgery performed in the US. . In all patients the fellow eye will act as the control.
Patients will be evaluated at 1 day, 1 week and 1 month postoperatively. Measurements are listed in the visit schedule table below. Patients will also be subjectively asked about their symptoms of pain and photophobia and be asked about their acceptance, cost, and which treatment protocol they preferred.
The purpose of this study is to evaluate the safety, effectiveness and patient acceptance of two post cataract surgery drug treatment regimens that minimize the use of topical medications. This will be a prospective evaluation of patients having routine, bilateral cataract surgery in which one eye of each subject will be randomized to receive a "conventional" regimen and the other eye will receive a regimen of "less drops". The "less drops" regimen will include EITHER (by randomization) a 0.1 cc subconjunctival injection of triamcinolone 40mg/mL (Triesence) at the end of surgery OR postoperative administration of topical clobetasol 0.05% (Byqlovi) BID for 14 days to deliver corticosteroid. Both steroid regimens will be delivered with nepafenac 0.3% QD for 14 days as a topical NSAID, and intracameral moxifloxacin 0.5% QID for 7 days as an antibiotic. The "conventional" topical medication regimen will include prednisolone acetate 1% QID, ketorolac 0.5% QID , and moxifloxacin 0.5% topical drops QID. With all of these treatment regimens, the patients will be receiving two on-label, FDA approved products and one (intracameral moxifloxacin) that is technically off-label but is so well accepted that it is used in approximately half the cataract surgery performed in the US. . In all patients the fellow eye will act as the control.
Patients will be evaluated at 1 day, 1 week and 1 month postoperatively. Measurements are listed in the visit schedule table below. Patients will also be subjectively asked about their symptoms of pain and photophobia and be asked about their acceptance, cost, and which treatment protocol they preferred.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: