Triamcinolone + Clobetasol for Cataract Surgery

(TRIBECA Trial)

Overseen By John Hovanesian, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Research Insight LLC

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

The TRIBECA Study is for individuals undergoing sequential bilateral cataract surgery. Participants must be suitable for the procedure and willing to follow postoperative medication instructions. Specific eligibility criteria are not provided, but typically participants should not have conditions that could interfere with the study or pose a risk.

Inclusion Criteria

Subject with normal OCT of the macula in both eyes

Subject has the potential for a post-operative Snellen BCDVA of 20/30 or better in both eyes

I understand the study and agree to participate.

Exclusion Criteria

Subject with a known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs) or to any component of the test article

Subject with amblyopia or strabismus

Subject with an inability to achieve keratometric stability for contact lens wearers

What Are the Treatments Tested in This Trial?

Interventions

• Triamcinolone

Trial Overview This study tests if subconjunctival triamcinolone (Triesence) after surgery, or topical clobetasol (Byqlovi) twice daily for two weeks, combined with standard medications, is as effective as traditional postoperative eye drops in controlling pain and inflammation after cataract surgery.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

Triesence or Byqlovi Arm with nepafenac

Group II: Control Group Active Control 1 Intervention

Topical Moxifloxacin, Ketorolac, Prednisolone Acetate

Who Is Running the Clinical Trial?

Research Insight LLC

Lead Sponsor

Trials

13

Recruited

900+