Post-Surgical Ocular PainPhase 4NCT04592081
Dextenza Within Upper Lid Canaliculus Compared With Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With PCIOL.
A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert in people with Post-Surgical Ocular Pain and Post-Surgical Ocular Inflammation, run by Kerry Assil, MD at 1 site in United States.
Trial summary
Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Surgical Ocular Pain, Post-Surgical Ocular Inflammation
- What is being tested?
- Dextenza 0.4Mg Ophthalmic Insert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 11 Mar 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Been diagnosed with clinically significant cataract and CE/PCIOL has been planned
- Bilateral cataract surgery with IOL has been planned
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Who cannot join
- Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- Active infectious systemic disease
- Active infectious ocular or extraocular disease
- Obstructed nasolacrimal duct in the study eye(s)
- Hypersensitivity to dexamethasone
- Patients being treated with immunomodulating agents in the study eye(s)
Show all 12Show fewer
- History of prior ocular surgery, excluding Lasik or PRK
- History of ocular inflammation or macular edema
- Use of any systemic NSAIDs greater than 375 mg per day
- Patients being treated with immunosuppressants and/or oral steroids
- Patients with a corticosteroid implant (i.e. Ozurdex)
- Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Assil Eye Institute
Beverly Hills, California, 90210
Lindsay Harris
Kerry Assil, MD
About this study
Official title: A Randomized Controlled Clinical Trial aSsessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert When Placed Within the Upper Eye Lid Canaliculus in Comparison to the Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With Posterior Chamber Intraocular Lens Implant (CE/PCIOL).
Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.
Read the detailed description
Randomized controlled clinical trial assessing the efficacy of DEXTENZA, sustained release dexamethasone 0.4 mg insert when placed within the upper eye lid canaliculus in comparison to the lower lid canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lens implant (CE/PCIOL).
- Being tested
- Dextenza 0.4Mg Ophthalmic Insert
- Keywords
- Dexamethasone, Cataract, Capsule Opacification, Inflammation, Lens Diseases, Eye Diseases, Anti-Inflammatory Agents
- Medical subject headings
- Cataract, Capsule Opacification, Inflammation, Lens Diseases, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextenza 0.4Mg Ophthalmic InsertDrug
Dextenza 0.4Mg Ophthalmic Insert
| Study group | Role | What they receive |
|---|---|---|
| DEXTENZA placed within the upper canaliculus | Experimental | Dextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation. Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert |
| DEXTENZA placed within the lower canaliculus | Active comparator | Dextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation. Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative inflammation scores
As measured on a scale of 0-4: absence of cell to be defined as a grade of 0-0.5, absence of flare to be defined as a grade of 0-1.
Measured: Assessed on Days 1, 7, 30 for change
Post-op pain scores
As measured on a scale from 0-10
Measured: Assessed on Days 1, 7, 30 for change
Secondary outcomes (7)
Ease of Insertion (successful implantation)
As measured by Physician Ease of Use Questionnaire
Measured: Assessed on Day 0 (Day of Insertion)
Intraocular Pressure
As measured by Goldmann Applanation
Measured: Assessed on Days 1, 7, 30, 90 for change
Visual Outcome
As measured by BCVA
Measured: Assessed at all time points;comparison of Day 30 vs Day 90
Absence of CME
As measured by OCT
Measured: Assessed on Day -30 to -1 and Day 90 for change
Need of additional steroids
As measured by rescue medication added
Measured: Assessed on Days 1, 7, 30, 90 for change
Absence of rebound iritis
As measured by presence of cells
Measured: Assessed on Days 1, 7, 30, 90 for change
Patient reported outcomes
As measured by patient questionnaire
Measured: Assessed on Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Aug 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion11 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Surgical Ocular PainStudies 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
- All patients will receive: First eye randomized for either lower lid (control eye) or upper lid (study eye) insertion and the contralateral eye receiving the opposite site insertion in the OR following CE/PCIOL
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kerry Assil, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kerry Assil, MD, Assil Eye Institute
- Investigators
- Kerry Assil, MD, Principal investigator, Assil Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04592081
- Sponsor's protocol ID
- The Assil Study
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2020
- Last updated
- 19 Oct 2020
- 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 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Clinical Trial aSsessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert When Placed Within the Upper Eye Lid Canaliculus in Comparison to the Lower Lid Canaliculus Following Bilateral Cataract Extraction Surgery With Posterior Chamber Intraocular Lens Implant (CE/PCIOL).
- ClinicalTrials.gov ID
- NCT04592081
- Acronym / sponsor ID
- The Assil Study
- Keywords
- Dexamethasone, Cataract, Capsule Opacification, Inflammation, Lens Diseases, Eye Diseases, Anti-Inflammatory Agents
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kerry Assil, MDUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 11 Mar 2021 (estimated)
- First posted
- 19 Oct 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.
Assessing DEXTENZA efficacy when placed within the upper eyelid canaliculus as opposed to the lower eyelid canaliculus.
Detailed description
Randomized controlled clinical trial assessing the efficacy of DEXTENZA, sustained release dexamethasone 0.4 mg insert when placed within the upper eye lid canaliculus in comparison to the lower lid canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lens implant (CE/PCIOL).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients will receive: First eye randomized for either lower lid (control eye) or upper lid (study eye) insertion and the contralateral eye receiving the opposite site insertion in the OR following CE/PCIOL
| Arm | Type | Receives |
|---|---|---|
| DEXTENZA placed within the upper canaliculus | Experimental | Drug: Dextenza 0.4Mg Ophthalmic InsertDextenza placed within the upper canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation. |
| DEXTENZA placed within the lower canaliculus | Active comparator | Drug: Dextenza 0.4Mg Ophthalmic InsertDextenza placed within the lower canaliculus following bilateral cataract extraction surgery with posterior chamber intraocular lenses implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Been diagnosed with clinically significant cataract and CE/PCIOL has been planned
- Bilateral cataract surgery with IOL has been planned
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Key exclusion criteria (12 listed)
- Pregnancy (must be ruled out in women of child-bearing age with pregnancy test)
- Active infectious systemic disease
- Active infectious ocular or extraocular disease
- Obstructed nasolacrimal duct in the study eye(s)
- Hypersensitivity to dexamethasone
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 0.4Mg Ophthalmic InsertDextenza 0.4Mg Ophthalmic Insert | Drug | DEXTENZA placed within the lower canaliculus, DEXTENZA placed within the upper canaliculus |
Primary outcome
Post-operative inflammation scores
Time frame: Assessed on Days 1, 7, 30 for change
As measured on a scale of 0-4: absence of cell to be defined as a grade of 0-0.5, absence of flare to be defined as a grade of 0-1.
Post-op pain scores
Time frame: Assessed on Days 1, 7, 30 for change
As measured on a scale from 0-10
7 secondary outcomes
Ease of Insertion (successful implantation)
Time frame: Assessed on Day 0 (Day of Insertion)
Intraocular Pressure
Time frame: Assessed on Days 1, 7, 30, 90 for change
Visual Outcome
Time frame: Assessed at all time points;comparison of Day 30 vs Day 90
Absence of CME
Time frame: Assessed on Day -30 to -1 and Day 90 for change
Need of additional steroids
Time frame: Assessed on Days 1, 7, 30, 90 for change
Absence of rebound iritis
Time frame: Assessed on Days 1, 7, 30, 90 for change
Patient reported outcomes
Time frame: Assessed on Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
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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.
Kerry Assil, MD principal investigator
Assil Eye Institute
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 Dextenza 0.4Mg Ophthalmic Insert in people with Post-Surgical Ocular Pain and Post-Surgical Ocular Inflammation, run by Kerry Assil, MD 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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 19 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kellie Burch (310-651-2392, kburch@assileye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative inflammation scores (time frame: Assessed on Days 1, 7, 30 for change). The study lists 2 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 19 Oct 2020.