Post Cataract SurgeryPhase 4TRIBECANCT07276802
The TRIBECA Study (TRIessence/Byqlovi for Easier CAtaract Surgery)
A Phase 4 study testing Triamcinolone (Optional) in people with Post Cataract Surgery, run by Research Insight LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Post Cataract Surgery
- What is being tested?
- Triamcinolone (Optional)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 31 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- A subject with a history of chronic/recurrent inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis) in either eye
- A subject with uncontrolled glaucoma
- A subject that requires the use of systemic or ocular medications that may affect vision, ocular inflammation or pain
- A subject with an acute or chronic disease, or illness, that would increase risk or confound study results (e.g., autoimmune disease, connective tissue disease, immunocompromised, suspected glaucoma, glaucomatous changes in the fundus or visual field, other source of ocular inflammation, etc.)
- A subject with an uncontrolled systemic disease: A potential subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study
- A subject with diabetes that is poorly controlled
- A subject currently participating or has participated in another clinical trial within 30 days prior to enrollment.
- Intra-Operative Exclusion Criteria (Surgical Complications):
- Sulcus-sulcus or bag-sulcus fixation
- Posterior capsular rupture or zonular dialysis
- Disruption of anterior hyaloid face
- Vitreous loss
- Floppy iris syndrome
- Inability to place IOL in capsular bag
- Significant anterior chamber hyphema
- Significant zonular rupture.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Leslie Lemieux, MHA contact
United States1 site
Harvard Eye Associates
Laguna Hills, California, 92653
About this study
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.
Read the 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.
- Conditions
- Post Cataract Surgery
- Being tested
- Triamcinolone (Optional), control group
- Keywords
- Interventional Study Design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone (Optional)Drug
Also called clobetasol
triamcinolone 40mg/ml or topical clobetasol 0.05% with nepafenac 0.3% QD for 14 days
control groupDrug
topical medication regimen will include prednisolone acetate 1% QID, ketorolac 0.5% QID, and moxifloxacin 0.5% topical drops QID.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Triesence or Byqlovi Arm with nepafenac Receives: Drug: Triamcinolone (Optional) |
| Control Group | Active comparator | Topical Moxifloxacin, Ketorolac, Prednisolone Acetate Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary
Patient Preference Between Medication Protocols (COMTOL Questionnaire Question 1)
Measured: 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)
Measured: 14 days after cataract surgery in each eye
Secondary outcomes (1)
Patient-Reported Postoperative Ocular Pain Severity Using a 0-10 Visual Analog Scale
Study subject evaluation of post-op ocular pain using a visual analog scale with pain ranking from 0 to 10 (10 high) with the request, "Please rate the severity of discomfort caused by your eye medicines at their worst point."
Measured: 14 days after cataract surgery in each eye
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Cataract SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Insight LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276802
- Sponsor's protocol ID
- 250501 TRIBECA
- Acronym
- TRIBECA
- Status last verified
- Oct 2025
- First submitted
- 30 Oct 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TRIBECA Study (TRIessence/Byqlovi for Easier CAtaract Surgery)
- ClinicalTrials.gov ID
- NCT07276802
- Acronym / sponsor ID
- TRIBECA / 250501 TRIBECA
- Conditions
- Post Cataract Surgery
- Keywords
- Interventional Study Design
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Research Insight LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: Triamcinolone (Optional)Triesence or Byqlovi Arm with nepafenac |
| Control Group | Active comparator | Drug: control groupTopical Moxifloxacin, Ketorolac, Prednisolone Acetate |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triamcinolone (Optional)Also: clobetasoltriamcinolone 40mg/ml or topical clobetasol 0.05% with nepafenac 0.3% QD for 14 days | Drug | Experimental Group |
| control grouptopical medication regimen will include prednisolone acetate 1% QID, ketorolac 0.5% QID, and moxifloxacin 0.5% topical drops QID. | Drug | Control Group |
Primary outcome
Primary
Time frame: 14 days after cataract surgery in each eye
Patient Preference Between Medication Protocols (COMTOL Questionnaire Question 1)
Primary
Time frame: 14 days after cataract surgery in each eye
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)
1 secondary outcome
Patient-Reported Postoperative Ocular Pain Severity Using a 0-10 Visual Analog Scale
Time frame: 14 days after cataract surgery in each eye
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leslie Lemieux, MHA contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triamcinolone (Optional) in people with Post Cataract Surgery, run by Research Insight LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Hovanesian, MD (949-951-2020, jhovanesian@researchinsight.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary (time frame: 14 days after cataract surgery in each eye). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.