The TRIBECA Study (TRIessence/Byqlovi for Easier CAtaract Surgery) (NCT07276802) | Clinical Trial Compass
Not Yet RecruitingPhase 4
The TRIBECA Study (TRIessence/Byqlovi for Easier CAtaract Surgery)
United States40 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range22 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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…
What they're measuring
1
Primary
Timeframe: 14 days after cataract surgery in each eye
2
Primary
Timeframe: 14 days after cataract surgery in each eye