PharmacokineticsPhase 4NCT04667507
Pharmacokinetics of Aqueous Dexamethasone
A Phase 4 study testing Dexamethasone Ophthalmic implant in people with Pharmacokinetics and Aqueous Dexamethasone, run by Frank A. Bucci, Jr., M.D. at 1 site in United States.
Trial summary
The study is being done to measure the absorption of the DEXTENZA implant and inflammation concentration levels in the eye. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Aqueous Dexamethasone, Inflammatory Cytokine Response
- What is being tested?
- Dexamethasone Ophthalmic implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 22 Jun 2022
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male of female, aged 55 or older
- Scheduled to undergo phacoemulsification with the intraocular lens (IOL) implantation for the treatment of cataract
- Willing to comply with study instructions, agree to make study appointments, and complete the course of the study
- Must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate
Who cannot join
- Known allergy or contraindication to the test article or its components
- Presence of any ocular abnormality or significant illness that, in the investigator's opinion, could affect the subject's health
- History of any illness that could be expected to interfere with the study
- Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or study
- May not be currently using topical or systemic steroids or NSAIDs during the course of the study or within 4 weeks prior to enrolling in the study other than Dextenza and Omidria
- Subject has active corneal, conjunctival, or canalicular infections, including:
Show all 12Show fewer
- Epithelial herpes simplex keratitis (dendritic keratitis)
- Vaccini
- Varicella
- Mycobacterial infections
- Fungal diseases of the eye
- Dacryocystitis
Trial locations and contacts
1 site in 1 country.
United States1 site
Bucci Laser Vision
Wilkes-Barre, Pennsylvania, 18702
About this study
Official title: The Pharmacokinetics of Aqueous Dexamethasone and the Inflammatory Cytokine Response After Treatment with a Dexamethasone Intracanalicular Insert - the CYTODEX Study
The study is being done to measure the absorption of the DEXTENZA implant and inflammation concentration levels in the eye.
- Being tested
- Dexamethasone Ophthalmic implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Ophthalmic implantDrug
Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use
| Study group | Role | What they receive |
|---|---|---|
| Dextenza (Group A) | Experimental | Dextenza (dexamethasone ophthalmic insert 0.4mg) 1-3 days prior to cataract surgery Receives: Drug: Dexamethasone Ophthalmic implant |
| Dextenza (Group B) | Experimental | Dextenza (dexamethasone ophthalmic insert 0.4mg) 6-8 days prior to surgery Receives: Drug: Dexamethasone Ophthalmic implant |
| Dextenza (Group C) | Experimental | Dextenza (dexamethasone ophthalmic insert 0.4mg) 13-15 days prior to surgery Receives: Drug: Dexamethasone Ophthalmic implant |
| Dextenza (Group D) | Experimental | Dextenza (dexamethasone ophthalmic insert 0.4mg) 19-23days prior to surgery Receives: Drug: Dexamethasone Ophthalmic implant |
| Dextenza (Group E) | Experimental | Dextenza (dexamethasone ophthalmic insert 0.4mg) 26-31 days prior to surgery Receives: Drug: Dexamethasone Ophthalmic implant |
| Control | No intervention | Will not receive Dextenza (dexamethasone ophthalmic insert 0.4mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics in Aqueous Humor Samples
Concentration of dexamethasone in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assasys. Pharmacokinetic parameters determined from aqueous humor concentration will minimally include maximum concentration (Cmax).
Measured: Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion
Pharmacokinetics in Aqueous Humor Samples
Concentration of inflammatory cytokines (IL-1 beta, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p70), IL-13, TNF alpha, and IFN gamma) in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assasys. Pharmacokinetic parameters determined from aqueous humor concentration will minimally include maximum concentration (Cmax).
Measured: Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion
Secondary outcomes (1)
Correlation between dexamethasone levels and inflammatory cytokines
Test for statistically significant correlations between the aqueous concentrations of dexamethasone and inflammatory cytokines (IL-1 beta, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p70), IL-13, TNF alpha, and IFN gamma) over time
Measured: 1-3 days, 6-8 days, 13-15 days, 19-23, or 26-31 days after Dextenza insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Jan 2021
- Primary completion31 Oct 2021
- Study completion22 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank A. Bucci, Jr., M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Frank A. Bucci, Jr., M.D., Bucci Laser Vision Institute
- Investigators
- Frank A Bucci, Jr., MD, Principal investigator, Bucci Laser Vision Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667507
- Sponsor's protocol ID
- IIT-CYTODEX
- Status last verified
- Oct 2022
- First submitted
- 21 Sep 2020
- Last updated
- 21 Oct 2024
- 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 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics of Aqueous Dexamethasone and the Inflammatory Cytokine Response After Treatment with a Dexamethasone Intracanalicular Insert - the CYTODEX Study
- ClinicalTrials.gov ID
- NCT04667507
- Acronym / sponsor ID
- IIT-CYTODEX
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Frank A. Bucci, Jr., M.D.University, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 22 Jun 2022 (actual)
- First posted
- 14 Dec 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.
The study is being done to measure the absorption of the DEXTENZA implant and inflammation concentration levels in the eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dextenza (Group A) | Experimental | Drug: Dexamethasone Ophthalmic implantDextenza (dexamethasone ophthalmic insert 0.4mg) 1-3 days prior to cataract surgery |
| Dextenza (Group B) | Experimental | Drug: Dexamethasone Ophthalmic implantDextenza (dexamethasone ophthalmic insert 0.4mg) 6-8 days prior to surgery |
| Dextenza (Group C) | Experimental | Drug: Dexamethasone Ophthalmic implantDextenza (dexamethasone ophthalmic insert 0.4mg) 13-15 days prior to surgery |
| Dextenza (Group D) | Experimental | Drug: Dexamethasone Ophthalmic implantDextenza (dexamethasone ophthalmic insert 0.4mg) 19-23days prior to surgery |
| Dextenza (Group E) | Experimental | Drug: Dexamethasone Ophthalmic implantDextenza (dexamethasone ophthalmic insert 0.4mg) 26-31 days prior to surgery |
| Control | No intervention | –Will not receive Dextenza (dexamethasone ophthalmic insert 0.4mg) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male of female, aged 55 or older
- Scheduled to undergo phacoemulsification with the intraocular lens (IOL) implantation for the treatment of cataract
- Willing to comply with study instructions, agree to make study appointments, and complete the course of the study
- Must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate
Key exclusion criteria (12 listed)
- Known allergy or contraindication to the test article or its components
- Presence of any ocular abnormality or significant illness that, in the investigator's opinion, could affect the subject's health
- History of any illness that could be expected to interfere with the study
- Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or study
- May not be currently using topical or systemic steroids or NSAIDs during the course of the study or within 4 weeks prior to enrolling in the study other than Dextenza and Omidria
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 |
|---|---|---|
| Dexamethasone Ophthalmic implantDexamethasone ophthalmic insert 0.4 mg for intracanalicular use | Drug | Dextenza (Group A), Dextenza (Group B), Dextenza (Group C), Dextenza (Group D), Dextenza (Group E) |
Primary outcome
Pharmacokinetics in Aqueous Humor Samples
Time frame: Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion
Concentration of dexamethasone in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assasys. Pharmacokinetic parameters determined from aqueous humor concentration will minimally include maximum concentration (Cmax).
Pharmacokinetics in Aqueous Humor Samples
Time frame: Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion
Concentration of inflammatory cytokines (IL-1 beta, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12 (p70), IL-13, TNF alpha, and IFN gamma) in the aqueous humor will be determined by an independent laboratory using standardized high-pressure liquid chromatography and mass spectrometry assasys. Pharmacokinetic parameters determined from aqueous humor concentration will minimally include maximum concentration (Cmax).
1 secondary outcome
Correlation between dexamethasone levels and inflammatory cytokines
Time frame: 1-3 days, 6-8 days, 13-15 days, 19-23, or 26-31 days after Dextenza insertion
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 21 Oct 2024.
- 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.
Frank A Bucci, Jr., MD principal investigator
Bucci Laser Vision 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 Dexamethasone Ophthalmic implant in people with Pharmacokinetics and Aqueous Dexamethasone, run by Frank A. Bucci, Jr., M.D. 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: finished, as of the sponsor's last update on 21 Oct 2024. 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?
Pharmacokinetics in Aqueous Humor Samples (time frame: Measured 1-3 days, 6-8 days, 13-15 days, 19-23 days, and 26-31 days after Dextenza insertion). 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 21 Oct 2024.