CataractPhase 3NCT05550350
A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
A Phase 3 study testing Dexycu in people with Cataract, run by EyePoint Pharmaceuticals, Inc..
Trial summary
A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- Dexycu
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2022to Sep 2023
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects at least 40 years of age scheduled for cataract surgery
- Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye
- Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye.
Who cannot join
- Use of any corticosteroids within 7 days prior to Day 0
- Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days
- Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening.
About this study
Official title: A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
Read the detailed description
A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated with Cataract Surgery
- Conditions
- Cataract
- Being tested
- Dexycu, Placebo/Vehicle
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexycuDrug
103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg
Placebo/VehicleOther
Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg
| Study group | Role | What they receive |
|---|---|---|
| DEXYCU | Experimental | DEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg Receives: Drug: Dexycu |
| Placebo | Placebo comparator | Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg Receives: Other: Placebo/Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8
Measured: Day 8
Secondary outcomes (7)
Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30
Measured: Days 1, 3, 15, and 30
Mean ocular pain scores in the study eye
Numerical Ocular Pain Scale from 0-10 with 0 being no pain and 10 being most severe
Measured: Days 1, 3, 8, 15 and 30
Proportion of subjects with absence of cells in the AC of the study eye
Measured: Days 1, 3, 8, 15 and 30
Proportion of subjects with absence of flare in the AC of the study eye
Measured: Days 1, 3, 8, 15 and 30
Mean AC cell score in the study eye
AC count by Slit Lamp Biomicroscopy with 0 being none and 4 being most severe
Measured: Days 1, 3, 8, 15 and 30
Mean AC flare score in the study eye
AC count by Slit Lamp Biomicroscopy with 0 being absent and 4 being strong intensity
Measured: Days 1, 3, 8, 15 and 30
Rates of ocular (study eye and fellow eye) and non-ocular TEAEs
Measured: up to day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: No longer pursuing indication
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT05550350
- Sponsor's protocol ID
- EYP-DIP-301
- Status last verified
- Aug 2025
- First submitted
- 16 Sep 2022
- Last updated
- 11 Aug 2025
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
- ClinicalTrials.gov ID
- NCT05550350
- Acronym / sponsor ID
- EYP-DIP-301
- Conditions
- Cataract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No longer pursuing indication
- Enrolment
- 0 participants (actual)
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 22 Sep 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 Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
Detailed description
A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated with Cataract Surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Randomized, Double-masked, Placebo-controlled,Parallel-design, Multicenter Study
| Arm | Type | Receives |
|---|---|---|
| DEXYCU | Experimental | Drug: DexycuDEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg |
| Placebo | Placebo comparator | Other: Placebo/VehiclePlacebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects at least 40 years of age scheduled for cataract surgery
- Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye
- Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye.
Key exclusion criteria (3 listed)
- Use of any corticosteroids within 7 days prior to Day 0
- Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days
- Score greater than "0" on the Ocular Pain Assessment in the study eye at 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 |
|---|---|---|
| Dexycu103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg | Drug | DEXYCU |
| Placebo/VehiclePlacebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg | Other | Placebo |
Primary outcome
Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8
Time frame: Day 8
7 secondary outcomes
Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30
Time frame: Days 1, 3, 15, and 30
Mean ocular pain scores in the study eye
Time frame: Days 1, 3, 8, 15 and 30
Proportion of subjects with absence of cells in the AC of the study eye
Time frame: Days 1, 3, 8, 15 and 30
Proportion of subjects with absence of flare in the AC of the study eye
Time frame: Days 1, 3, 8, 15 and 30
Mean AC cell score in the study eye
Time frame: Days 1, 3, 8, 15 and 30
Mean AC flare score in the study eye
Time frame: Days 1, 3, 8, 15 and 30
Rates of ocular (study eye and fellow eye) and non-ocular TEAEs
Time frame: up to day 30
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexycu in people with Cataract, run by EyePoint Pharmaceuticals, Inc..
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 3 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: withdrawn, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 withdrawn before enrolling participants, so there are no results.
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?
Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8 (time frame: Day 8). 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 11 Aug 2025.