CataractPhase 3NCT04539548
A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
A Phase 3 study testing Dextenza Ophthalmic Insert and Prednisolone acetate ophthalmic suspension USP 1% in people with Cataract, run by Ocular Therapeutix, Inc. at 14 sites in United States.
Trial summary
To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract. Read more about this study
- Who is it for?
- Ages 0 to 5 years
- Conditions the study is for
- Cataract
- What is being tested?
- Dextenza Ophthalmic Insert and Prednisolone acetate ophthalmic suspension USP 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 14 sitesUnited States
- Study dates
- 4 Sep 2020to 21 Dec 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 0 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Is 0-5 years of age (up to the day before the subject turns 6 years of age). In the event that a subject aged 0-5 years enrolls in the study and then undergoes a second cataract surgery in the contralateral eye during the study period, the subject remains eligible for participation for both eyes, regardless if the second surgery occurs when the subject is >5 years of age)
- Has a cataract and is expected to undergo primary cataract surgery with or without implantation of a posterior chamber intraocular lens
Who cannot join
- Any intraocular inflammation in the study eye present during the screening slit lamp examination
- Has ocular hypertension (defined as IOP of >21 mmHg), or glaucoma or is on medications to treat ocular hypertension or glaucoma or has a history of IOP spikes in either eye including steroid-related IOP increases
- Evidence of acute external ocular infections (bacterial, viral and/or fungal such as vaccinia, varicella, and other viral diseases of the cornea and conjunctiva), tuberculosis of the eye; corneal dystrophies; active corneal ulcers, intraocular infections, dysthyroid ophthalmopathy, active chalazion, or uncontrolled blepharitis in the study eye
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Ocular Therapeutix
Aurora, Colorado, 80045
Ocular Therapeutix
Boston, Massachusetts, 02115
Ocular Therapeutix
Charleston, South Carolina, 29425
Ocular Therapeutix
Erie, Pennsylvania, 16501
Ocular Therapeutix
Fort Collins, Colorado, 80525
Ocular Therapeutix
Indianapolis, Indiana, 46202
Ocular Therapeutix
Jacksonville, Florida, 32202
Ocular Therapeutix
Lexington, Kentucky, 40508
Ocular Therapeutix
Madison, Wisconsin, 53705
Ocular Therapeutix
Minneapolis, Minnesota, 55454
Ocular Therapeutix
Nashville, Tennessee, 37232
Ocular Therapeutix
Rochester, Minnesota, 55905
Ocular Therapeutix
St Louis, Missouri, 63110
Ocular Therapeutix
Virginia Beach, Virginia, 23452
About this study
Official title: A Randomized, Parallel-Arm, Active Control, Multi-Center Study Assessing the Safety And Efficacy Of Dextenza® for the Treatment Of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.
Read the detailed description
Randomized, parallel-arm, active control, multi-center study assessing the safety of Dextenza for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The subjects will be followed for approximately 2-3 months from screening to the last visit.
- Conditions
- Cataract
- Being tested
- Dextenza Ophthalmic Insert, Prednisolone acetate ophthalmic suspension USP 1%
- Keywords
- Dextenza, dexamethasone ophthalmic insert
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextenza Ophthalmic InsertDrug
Also called DEXTENZA
0.4mg insert for intracanalicular use
Prednisolone acetate ophthalmic suspension USP 1%Drug
1 drop at end of surgery, followed by:
1 drop 4 x QID for one week.
1 drop 3 x QID for one week.
1 drop BID for one week.
1 drop QD for one week
| Study group | Role | What they receive |
|---|---|---|
| Dextenza | Experimental | 1 dosing group - 37 eyes treated with Dextenza Receives: Drug: Dextenza Ophthalmic Insert |
| Prednisolone | Active comparator | 1 dosing group - 32 eyes treated with Prednisolone Receives: Drug: Prednisolone acetate ophthalmic suspension USP 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of Ocular Treatment Emergent Adverse Events (TEAEs) and Non-ocular Treatment Emergent Adverse Events (TEAEs)
Measured: Up to approximately 42 days after surgery
Subject FLACC Pain Assessment
Behavioral Observation Pain Rating Scale from 0 (no pain) to 10 (most pain).
Measured: From screening through day 42
IOP
IOP measured in units of mmHg.
Measured: From screening, then day 2 through 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start4 Sep 2020
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
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
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ocular Therapeutix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539548
- Sponsor's protocol ID
- CLN-Protocol-0050
- Status last verified
- Apr 2024
- First submitted
- 27 Aug 2020
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Parallel-Arm, Active Control, Multi-Center Study Assessing the Safety And Efficacy Of Dextenza® for the Treatment Of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
- ClinicalTrials.gov ID
- NCT04539548
- Acronym / sponsor ID
- CLN-Protocol-0050
- Conditions
- Cataract
- Keywords
- Dextenza, dexamethasone ophthalmic insert
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Ocular Therapeutix, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Sep 2020 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 7 Sep 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.
To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.
Detailed description
Randomized, parallel-arm, active control, multi-center study assessing the safety of Dextenza for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The subjects will be followed for approximately 2-3 months from screening to the last visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextenza | Experimental | Drug: Dextenza Ophthalmic Insert1 dosing group - 37 eyes treated with Dextenza |
| Prednisolone | Active comparator | Drug: Prednisolone acetate ophthalmic suspension USP 1%1 dosing group - 32 eyes treated with Prednisolone |
Who may qualify
- Ages
- 0 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Is 0-5 years of age (up to the day before the subject turns 6 years of age). In the event that a subject aged 0-5 years enrolls in the study and then undergoes a second cataract surgery in the contralateral eye during the study period, the subject remains eligible for participation for both eyes, regardless if the second surgery occurs when the subject is >5 years of age)
- Has a cataract and is expected to undergo primary cataract surgery with or without implantation of a posterior chamber intraocular lens
Key exclusion criteria (3 listed)
- Any intraocular inflammation in the study eye present during the screening slit lamp examination
- Has ocular hypertension (defined as IOP of >21 mmHg), or glaucoma or is on medications to treat ocular hypertension or glaucoma or has a history of IOP spikes in either eye including steroid-related IOP increases
- Evidence of acute external ocular infections (bacterial, viral and/or fungal such as vaccinia, varicella, and other viral diseases of the cornea and conjunctiva), tuberculosis of the eye; corneal dystrophies; active corneal ulcers, intraocular infections, dysthyroid ophthalmopathy, active chalazion, or uncontrolled blepharitis in the study eye
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 |
|---|---|---|
| Dextenza Ophthalmic InsertAlso: DEXTENZA0.4mg insert for intracanalicular use | Drug | Dextenza |
| Prednisolone acetate ophthalmic suspension USP 1%1 drop at end of surgery, followed by: 1 drop 4 x QID for one week. 1 drop 3 x QID for one week. 1 drop BID for one week. 1 drop QD for one week | Drug | Prednisolone |
Primary outcome
Adverse Events
Time frame: Up to approximately 42 days after surgery
Number of Ocular Treatment Emergent Adverse Events (TEAEs) and Non-ocular Treatment Emergent Adverse Events (TEAEs)
Subject FLACC Pain Assessment
Time frame: From screening through day 42
Behavioral Observation Pain Rating Scale from 0 (no pain) to 10 (most pain).
IOP
Time frame: From screening, then day 2 through 42
IOP measured in units of mmHg.
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 Apr 2024.
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dextenza Ophthalmic Insert and Prednisolone acetate ophthalmic suspension USP 1% in people with Cataract, run by Ocular Therapeutix, Inc. at 14 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 2 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: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 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 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?
Adverse Events (time frame: Up to approximately 42 days after surgery). 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 Apr 2024.