The TRIBECA Study (TRIessence/Byqlovi for Easier CAtaract Surgery)

NCT07276802 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 250501 TRIBECA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Cataract Surgery

Keywords

Interventional Study Design

Outcome Measures

Primary Outcomes (2)

• Primary

  Patient Preference Between Medication Protocols (COMTOL Questionnaire Question 1)

  14 days after cataract surgery in each eye

• Primary

  Patient preference for medication protocol between the two eyes, as reported based on the question, "Thinking about your overall experience taking medications in each eye after surgery, which eye did you prefer?" (question 1 from validated COMTOL questionnaire)

  14 days after cataract surgery in each eye

Secondary Outcomes (1)

• Patient-Reported Postoperative Ocular Pain Severity Using a 0-10 Visual Analog Scale

  14 days after cataract surgery in each eye

Other Outcomes (1)

• Summed Ocular Inflammation Score at One Week (Anterior Chamber Cells + Flare)

  7 days after cataract surgery in each eye

Study Arms (2)

Experimental Group

EXPERIMENTAL

Triesence or Byqlovi Arm with nepafenac

Drug: Triamcinolone (Optional)

Control Group

ACTIVE COMPARATOR

Topical Moxifloxacin, Ketorolac, Prednisolone Acetate

Drug: control group

Interventions

Triamcinolone (Optional) DRUG

triamcinolone 40mg/ml or topical clobetasol 0.05% with nepafenac 0.3% QD for 14 days

Also known as: clobetasol

Experimental Group

control group DRUG

topical medication regimen will include prednisolone acetate 1% QID, ketorolac 0.5% QID, and moxifloxacin 0.5% topical drops QID.

Control Group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A male or female subject in good general health, \> 22 years of age at the time of the screening visit
• A subject must be able to comprehend and willing to give informed consent
• A woman of child-bearing potential must not be pregnant or lactating.
• A subject has the availability, willingness and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits
• A subject with a cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned
• A subject with clear ocular media other than cataract in their scheduled operative eye
• A subject with normal OCT of the macula in both eyes
• A subject has the potential for a post-operative Snellen BCDVA of 20/30 or better in both eyes

You may not qualify if:

• A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in either eye
• A subject with any moderate to severe lid, conjunctival or corneal findings in either eye at the screening visit
• A subject with any signs of intraocular inflammation (cells/flare) in either eye at the screening visit
• A subject with a known sensitivity to any of the study medications.
• A subject with a history as a steroid responder or glaucoma
• A subject with a known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article
• A subject with only one eye with potentially good vision
• A subject with a known pathology that may affect visual acuity (as determined by the Investigator); particularly retinal changes that affect vision (macular degeneration, cystoid macular edema, proliferative diabetic retinopathy, etc.) in their scheduled surgical eye
• A subject that has a condition associated with the fluctuation of hormones that could lead to refractive changes
• A subject with amblyopia or strabismus
• A subject has a history of ocular trauma in their scheduled surgical eye
• A subject that has undergone prior intraocular surgery in the scheduled surgical eye within the last 6 months or laser surgery within three months prior to screening
• A subject with pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions) in their scheduled surgical eye.
• A subject with a clinically significant corneal abnormality (e.g., stromal, epithelial or endothelial dystrophies) that, in the best judgment of the investigator, is likely to interfere with the outcomes of the study
• A subject with an inability to achieve keratometric stability for contact lens wearers

Sponsors & Collaborators

• Research Insight LLC: lead

Study Sites (1)

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

MeSH Terms

Interventions

Triamcinolone; Clobetasol; Control Groups

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Betamethasone; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

John Hovanesian, MD

CONTACT

949-951-2020; jhovanesian@researchinsight.com

Leslie Lemieux, MHA

CONTACT

research@researchinsightca.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2025
• First Posted: December 11, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 31, 2026

Record last verified: 2025-10

Locations

US (1)