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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 4INTERVENTIONAL

A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery

A Prospective Trial Evaluating a Intracanalicular Insert Delivery System Compared to Traditional Topical Drops in Controlling Post-operative Pain and inFlammation in Subjects Undergoing Sequential Bilateral Cataract Surgery

A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery (NCT04205916) is a Phase 4 interventional studying Patient Preference, sponsored by Ophthalmic Consultants of Long Island. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery.

What Stage of Research Is This?

Phase 4 studies happen after a treatment has been approved by the FDA. They monitor long-term safety, real-world effectiveness, and any rare side effects that only emerge in larger populations over longer periods. Phase 4 results sometimes lead to label changes, additional warnings, or — rarely — withdrawal of approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 50 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Patient Preference subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - A male or female subject in good general health (as determined by the Investigator), \> 22 years of age at the time of the screening visit - A subject must be willing and able to sign willing to sign a consent form - A woman of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD), oral, dermal ("patch"), implant or injected contraceptives; tubal ligation; and barrier methods with spermicide. - 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 Who Should NOT Join This Trial: - 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 structural lid abnormalities (e.g., ectropion, entropion) in their schedule surgical eye - A subject with a puncta \>0.9 mm prior to dilation in their scheduled surgical eye - A subject experiencing significant ocular pain or discomfort in either eye at the screening visit or on the day the plug is to be inserted - 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 known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article - A subject with a history as a steroid responder ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * A male or female subject in good general health (as determined by the Investigator), \> 22 years of age at the time of the screening visit * A subject must be willing and able to sign informed consent * A woman of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD), oral, dermal ("patch"), implant or injected contraceptives; tubal ligation; and barrier methods with spermicide. * 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 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 structural lid abnormalities (e.g., ectropion, entropion) in their schedule surgical eye * A subject with a puncta \>0.9 mm prior to dilation in their scheduled surgical eye * A subject experiencing significant ocular pain or discomfort in either eye at the screening visit or on the day the plug is to be inserted * 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 known or suspected allergy or hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), or to any component of the test article * A subject with a history as a steroid responder * A subject with capsule or zonular abnormalities with preoperative lens tilt and/or decentration (e.g., Marfan's syndrome), or may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome) * 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 corneal abnormality (e.g., stromal, epithelial or endothelial dystrophies) in their scheduled surgical eye * A subject with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in their scheduled surgical eye * A subject with evidence of Epithelial Basement Membrane Dystrophy on slit-lamp exam * A subject that has been wearing Poly Methyl Metharcylate (PMMA) lenses within 6 months, gas permeable lenses within one month, or extended-wear or daily soft contact lens within 7 days of their scheduled surgery * 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 an Limbal Relaxing Incision (LRI) or AI procedure before, during or after cataract surgery * A subject that may or is expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period * A subject that requires the use of systemic or ophthalmic Nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroid medications during the study period. * A subject that requires the use of system 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, 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 hyaloids face * Vitreous loss * Capsulorhexis tear * Floppy iris syndrome * Requirement for the use of trypan blue, capsular tension ring or other intraocular device other than the Intra ocular lens (IOL) * Inability to place IOL in capsular bag * Significant anterior chamber hyphema * Zonular rupture.

Treatments Being Tested

DRUG

Dexamethasone

Drugs to be administer during cataract surgery to experimental group

OTHER

Standard of care surgery

Standard method used for surgery and the use of post operative drops

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Ophthalmic Consultants of Long Island
Garden City, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04205916), the sponsor (Ophthalmic Consultants of Long Island), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04205916 clinical trial studying?

To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04205916?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04205916?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04205916. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04205916. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.