Cataract SurgeryPhase 4NCT04316936
Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery
A Phase 4 study testing Omidria, Dextenza (dexamethasone ophthalmic insert) 0.4mg and Dexycu, 9% Intraocular Suspension in people with Cataract Surgery, run by Silverstein Eye Centers at 1 site in United States.
Trial summary
This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract Surgery
- What is being tested?
- Omidria, Dextenza (dexamethasone ophthalmic insert) 0.4mg and Dexycu, 9% Intraocular Suspension
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2019to 23 Dec 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients 18 years of age or older, undergoing routine, uncomplicated cataract surgery.
Who cannot join
- Any history of corneal dystrophy, corneal surgery within 6 months of cataract surgery, previous intraocular surgery, any concomitant eye drop use besides artificial tears, previous ocular trauma, or a history of treated glaucoma. No additional procedures can be done at the time of cataract surgery (e.g., stent placement, endo-laser, etc.), but femto-second laser-assisted surgery is permitted.
Trial locations and contacts
1 site in 1 country.
United States1 site
Silverstein Eye Centers
Kansas City, Missouri, 64133
About this study
Official title: Evaluation of Efficacy in the Resolution of Post-Operative Inflammation and Pain in Patients Receiving Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery
This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.
Read the detailed description
Prospective, randomized trial where patients will be randomly assigned to 1 of 3 groups, each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria. Each of the drug combinations used in each of the 3 groups is standard of care, FDA approved, and will be used on label. 1:1:1, n=75 with 25 subjects assigned to each of the 3 groups.
- Conditions
- Cataract Surgery
- Being tested
- Omidria, Dextenza (dexamethasone ophthalmic insert) 0.4mg, Dexycu, 9% Intraocular Suspension, Prednisolone Acetate 1%
- Keywords
- Dextenza, intracanalicular dexamethasone, dexamethasone ophthalmic insert, Dexycu, Omidria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmidriaDrug
phenylephrine 1% and ketorolac 0.3% intraocular solution
Dextenza (dexamethasone ophthalmic insert) 0.4mgDrug
intracanalicular dexamethasone insert
Dexycu, 9% Intraocular SuspensionDrug
dexamethasone intraocular suspension
Prednisolone Acetate 1%Drug
standard postoperative ophthalmic drop regimen
| Study group | Role | What they receive |
|---|---|---|
| Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg | Experimental | Omidria (= ketorolac + phenylephrine) and intracanalicular dexamethasone insert (punctal plug) Receives: Drug: Omidria; Drug: Dextenza (dexamethasone ophthalmic insert) 0.4mg |
| Omidria + Dexycu | Experimental | Omidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension Receives: Drug: Omidria; Drug: Dexycu, 9% Intraocular Suspension |
| Omidria + Prednisolone Acetate 1% | Active comparator | Omidria (= ketorolac + phenylephrine) and topical prednisolone acetate ophthalmic drops Receives: Drug: Omidria; Drug: Prednisolone Acetate 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of anterior chamber inflammation
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
Measured: Assessed at day 8 post-operatively
Resolution of anterior chamber inflammation
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
Measured: Assessed at day 15 post-operatively
Resolution of anterior chamber inflammation
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
Measured: Assessed at day 30 post-operatively
Secondary outcomes (2)
Resolution of postoperative pain
The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment).
Measured: Assessed at day 1 post-operatively
Resolution of postoperative pain
The secondary efficacy endpoint is the elimination of post-operative pain per a subjective, standardized scale. Post-operative pain as measured on a scale from 0-10 (ocular pain assessment).
Measured: Assessed at day 8 post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2020
- Study start10 Dec 2019
- Primary completion23 Dec 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly assigned to 1 of 3 groups (1:1:1), each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silverstein Eye Centers
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04316936
- Sponsor's protocol ID
- 1
- Status last verified
- Jun 2023
- First submitted
- 17 Mar 2020
- Last updated
- 15 Jun 2023
- 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 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy in the Resolution of Post-Operative Inflammation and Pain in Patients Receiving Omidria and Dexycu, or Omidria and Dextenza Compared to Topical Prednisolone Acetate 1% Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT04316936
- Acronym / sponsor ID
- 1
- Conditions
- Cataract Surgery
- Keywords
- Dextenza, intracanalicular dexamethasone, dexamethasone ophthalmic insert, Dexycu, Omidria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Silverstein Eye CentersUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 23 Dec 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 20 Mar 2020 (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.
This research will evaluate the efficacy of Omidria and Dexycu, Omidria and Dextenza, and Omidria and prednisolone acetate 1% in the resolution of post-operative inflammation and pain following cataract surgery.
Detailed description
Prospective, randomized trial where patients will be randomly assigned to 1 of 3 groups, each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria. Each of the drug combinations used in each of the 3 groups is standard of care, FDA approved, and will be used on label. 1:1:1, n=75 with 25 subjects assigned to each of the 3 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients will be randomly assigned to 1 of 3 groups (1:1:1), each with a sample size of 25 (total n=75). Group 1 will receive DEXYCU + Omidria (Omidria = ketorolac + phenylephrine), group 2 will receive DEXTENZA + Omidria, and group 3 will receive prednisolone acetate + Omidria.
| Arm | Type | Receives |
|---|---|---|
| Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg | Experimental | Drug: Omidria, Drug: Dextenza (dexamethasone ophthalmic insert) 0.4mgOmidria (= ketorolac + phenylephrine) and intracanalicular dexamethasone insert (punctal plug) |
| Omidria + Dexycu | Experimental | Drug: Omidria, Drug: Dexycu, 9% Intraocular SuspensionOmidria (= ketorolac + phenylephrine) and intraocular dexamethasone suspension |
| Omidria + Prednisolone Acetate 1% | Active comparator | Drug: Omidria, Drug: Prednisolone Acetate 1%Omidria (= ketorolac + phenylephrine) and topical prednisolone acetate ophthalmic drops |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients 18 years of age or older, undergoing routine, uncomplicated cataract surgery.
Key exclusion criteria (1 listed)
- Any history of corneal dystrophy, corneal surgery within 6 months of cataract surgery, previous intraocular surgery, any concomitant eye drop use besides artificial tears, previous ocular trauma, or a history of treated glaucoma. No additional procedures can be done at the time of cataract surgery (e.g., stent placement, endo-laser, etc.), but femto-second laser-assisted surgery is permitted.
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 |
|---|---|---|
| Omidriaphenylephrine 1% and ketorolac 0.3% intraocular solution | Drug | Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg, Omidria + Dexycu, Omidria + Prednisolone Acetate 1% |
| Dextenza (dexamethasone ophthalmic insert) 0.4mgintracanalicular dexamethasone insert | Drug | Omidria + Dextenza (dexamethasone ophthalmic insert) 0.4mg |
| Dexycu, 9% Intraocular Suspensiondexamethasone intraocular suspension | Drug | Omidria + Dexycu |
| Prednisolone Acetate 1%standard postoperative ophthalmic drop regimen | Drug | Omidria + Prednisolone Acetate 1% |
Primary outcome
Resolution of anterior chamber inflammation
Time frame: Assessed at day 8 post-operatively
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
Resolution of anterior chamber inflammation
Time frame: Assessed at day 15 post-operatively
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
Resolution of anterior chamber inflammation
Time frame: Assessed at day 30 post-operatively
The primary efficacy end point is the complete resolution of anterior chamber inflammation (cell and flare). This is a non-contact, non-invasive test performed by the physician using a slit lamp. The evaluation requires less than one minute.
2 secondary outcomes
Resolution of postoperative pain
Time frame: Assessed at day 1 post-operatively
Resolution of postoperative pain
Time frame: Assessed at day 8 post-operatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
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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.
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 Omidria, Dextenza (dexamethasone ophthalmic insert) 0.4mg and Dexycu, 9% Intraocular Suspension in people with Cataract Surgery, run by Silverstein Eye Centers 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 15 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Resolution of anterior chamber inflammation (time frame: Assessed at day 8 post-operatively). The study lists 3 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 15 Jun 2023.