CataractPhase 4NCT05191706
Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
A Phase 4 study testing Dexamethasone and Prednisolone Acetate Ophthalmic in people with Cataract, run by EyePoint Pharmaceuticals, Inc. at 9 sites in United States.
Trial summary
A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Cataract
- What is being tested?
- Dexamethasone and Prednisolone Acetate Ophthalmic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 9 sitesUnited States
- Study dates
- 4 Jan 2022to 22 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Up to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Undergoing uncomplicated cataract surgery with or without a posterior chamber intraocular lens (IOL) implantation.
- If a contact lens is used for correction of post-operative aphakia, it must be a silicone elastomer lens or a rigid gas permeable lens (no water content).
- Other protocol-specified inclusion criteria may apply.
Who cannot join
- Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory, or other medical condition that could increase the risk to the subject as determined by the investigator.
- Has a post-traumatic cataract.
- Presence of active or suspected viral, bacterial, or fungal disease in the study eye.
- Ocular hypertension with an IOP in the study eye >25 mmHg at Screening with or without treatment with anti-glaucoma monotherapy.
- Subjects who have received a periocular corticosteroid injection in the study eye in the 3 months prior to Screening.
- Subjects who have received any intravitreal corticosteroid delivery vehicle (eg, Retisert®, Ozurdex®, Iluvien®) in the study eye at any time.
- Other protocol-specified exclusion criteria may apply
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
EyePoint Investigative Site
Boston, Massachusetts, 02118
EyePoint Investigational Site
Buffalo, New York, 14209
EyePoint Investigational Site
Charleston, South Carolina, 29425
EyePoint Investigational Site
Huntington Beach, California, 92647
EyePoint Investigational Site
Jackson, Mississippi, 39216
EyePoint Investigative Site
New York, New York, 10032
EyePoint Investigational Site
Omaha, Nebraska, 68114
EyePoint Investigational Site
Palo Alto, California, 94303
EyePoint Investigational Site
Rochester, New York, 14642
About this study
Official title: A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
- Conditions
- Cataract
- Being tested
- Dexamethasone, Prednisolone Acetate Ophthalmic
- Keywords
- pediatric, cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
single anterior chamber injection
Prednisolone Acetate OphthalmicDrug
topical administration four times a day for 28 days, followed by treatment taper
| Study group | Role | What they receive |
|---|---|---|
| DEXYCU (dexamethasoneintraocular suspension) 9% | Experimental | A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone. Receives: Drug: Dexamethasone |
| Prednisolone acetate ophthalmic suspension (USP) 1% | Active comparator | Active treatment control, prednisolone acetate ophthalmic suspension (USP) 1%, four times daily (QID) for 28days, followed by a treatment taper at the investigator's discretion. Receives: Drug: Prednisolone Acetate Ophthalmic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade of anterior chamber cells (ACC)
Measured: Post-Operative Day 14
Secondary outcomes (1)
Grade of anterior chamber flare (ACF)
Measured: Post-Operative Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start4 Jan 2022
- Primary completion22 Aug 2025
- Study completion22 Aug 2025
Why it stopped: EyePoint has submitted withdrawal of the NDA to the FDA for reasons unrelated to safety or efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191706
- Sponsor's protocol ID
- EYP-DIP-001
- Status last verified
- Oct 2026
- First submitted
- 13 Dec 2021
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
- ClinicalTrials.gov ID
- NCT05191706
- Acronym / sponsor ID
- EYP-DIP-001
- Conditions
- Cataract
- Keywords
- pediatric, cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: EyePoint has submitted withdrawal of the NDA to the FDA for reasons unrelated to safety or efficacy
- Enrolment
- 17 participants (actual)
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 13 Jan 2022 (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 Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study
| Arm | Type | Receives |
|---|---|---|
| DEXYCU (dexamethasoneintraocular suspension) 9% | Experimental | Drug: DexamethasoneA single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone. |
| Prednisolone acetate ophthalmic suspension (USP) 1% | Active comparator | Drug: Prednisolone Acetate OphthalmicActive treatment control, prednisolone acetate ophthalmic suspension (USP) 1%, four times daily (QID) for 28days, followed by a treatment taper at the investigator's discretion. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Undergoing uncomplicated cataract surgery with or without a posterior chamber intraocular lens (IOL) implantation.
- If a contact lens is used for correction of post-operative aphakia, it must be a silicone elastomer lens or a rigid gas permeable lens (no water content).
- Other protocol-specified inclusion criteria may apply.
Key exclusion criteria (7 listed)
- Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory, or other medical condition that could increase the risk to the subject as determined by the investigator.
- Has a post-traumatic cataract.
- Presence of active or suspected viral, bacterial, or fungal disease in the study eye.
- Ocular hypertension with an IOP in the study eye >25 mmHg at Screening with or without treatment with anti-glaucoma monotherapy.
- Subjects who have received a periocular corticosteroid injection in the study eye in the 3 months prior to Screening.
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 |
|---|---|---|
| Dexamethasonesingle anterior chamber injection | Drug | DEXYCU (dexamethasoneintraocular suspension) 9% |
| Prednisolone Acetate Ophthalmictopical administration four times a day for 28 days, followed by treatment taper | Drug | Prednisolone acetate ophthalmic suspension (USP) 1% |
Primary outcome
Grade of anterior chamber cells (ACC)
Time frame: Post-Operative Day 14
1 secondary outcome
Grade of anterior chamber flare (ACF)
Time frame: Post-Operative Day 14
Results and safety
The study was stopped early (reason given: EyePoint has submitted withdrawal of the NDA to the FDA for reasons unrelated to safety or efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Prednisolone Acetate Ophthalmic in people with Cataract, run by EyePoint Pharmaceuticals, Inc. at 9 sites 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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The study was stopped early (reason given: EyePoint has submitted withdrawal of the NDA to the FDA for reasons unrelated to safety or efficacy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grade of anterior chamber cells (ACC) (time frame: Post-Operative Day 14). 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 5 Oct 2026.