Glaucoma Following SurgeryPhase 4DEXTenSiVeNCT05116345
DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures
A Phase 4 study testing DEXTENZA and Topical Dexamethasone in people with Glaucoma Following Surgery, run by Brian Jerkins, MD at 1 site in United States.
Trial summary
This is a prospective, comparative, open-label, single-center, randomized, investigator-sponsored clinical study and seeks to investigate clinical outcomes with standard of care and high dose DEXTENZA treatment compared to standard of care topical dexamethasone in patients undergoing trabeculectomy, trabeculectomy… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma Following Surgery
- What is being tested?
- DEXTENZA and Topical Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2021to Nov 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide signed written consent prior to participation in any study-related procedures
- Patient is diagnosed with glaucoma and undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, or Ahmed Valve surgery
Who cannot join
- Have used topical corticosteroid treatment up to 48 hours prior to the baseline visit
- Have used oral corticosteroid within the past 14 days prior to baseline visit (Patients using stable doses of inhaled corticosteroids for 30 days prior to baseline visit can be included in the study)
- Have received intravitreal or sub-Tenon corticosteroid treatment prior to baseline visit or Ozurdex ® in the study eye within the 6 months prior to the baseline visit
- Are currently using prescribed nonsteroidal anti-inflammatory agents or prescribed immunosuppressive agents, unless the dose has been stable for the last 6 weeks and no change in dosing is anticipated for the duration of the study
- Are pregnant or lactating female, or female of childbearing age using inadequate birth control method
- Have participated in another investigational device or drug study within 30 days of the baseline visit
- Anterior chamber cells present at time of enrollment
- Known allergy to dexamethasone or prednisolone
Trial locations and contacts
1 site in 1 country.
United States1 site
Hamilton Eye Institute
Memphis, Tennessee, 38103
Brian Jerkins, MD, 901-338-1022, bjerkins@uthsc.edu
Breia N. Dooley, MA, 901-448-3269, bdooley3@uthsc.edu
About this study
This is a prospective, comparative, open-label, single-center, randomized, investigator-sponsored clinical study and seeks to investigate clinical outcomes with standard of care and high dose DEXTENZA treatment compared to standard of care topical dexamethasone in patients undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, and Ahmed Valve surgery. Patients will be followed through 6 months. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, eyes of n=30 patients will be randomized to one of the following two groups (n=15per group) and followed from Baseline through Month 6.
- Conditions
- Glaucoma Following Surgery
- Being tested
- DEXTENZA, Topical Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEXTENZADrug
Also called Dexamethasone (0.4mg) Insert
Intracanalicular Dexamethasone ophthalmic insert (0.4mg)
Topical DexamethasoneDrug
topical dexamethasone drops
| Study group | Role | What they receive |
|---|---|---|
| DEXTENZA | Experimental | a single intracanalicular dexamethasone (0.4 mg) insert Receives: Drug: DEXTENZA |
| Topical Dexamethasone Treatment | Active comparator | Standard of care topical dexamethasone treatment through Month 2 dosing and tapering following:
6x/day week 1 4x/day weeks 2-4 2x/day weeks 5-8 Day of surgery dexamethasone ointment and patch will be applied post-surgically for overnight treatment and removed at post-operative day 1 visit in Group B eyes. Receives: Drug: Topical Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in intraocular pressure (IOP)
mean change in intraocular pressure (IOP) from day of surgery and proportion of eyes requiring additional topical dexamethasone or anti-metabolite therapy over time
Measured: From baseline through month 6
Secondary outcomes (8)
Mean change in best corrected visual acuity (BCVA)
Mean change in BCVA using Snellen eye charts
Measured: From baseline through month 6
Mean change in Visual Field (MD)
Mean change in Visual Field (MD) will be detected using a perimeter device. The patient looks into the perimeter at a center target. Only one eye is tested at a time. The eye not being tested is covered with an eye patch. Small, dim lights will flash in the device and the patient will press a button each time they see the light. The results will show if the patient has had any changes in their visual field.
Measured: From baseline through month 6
Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development
Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development
Measured: From baseline through month 6
Proportion of eyes with absence of anterior chamber (AC) cells (score of 0) as measured by the Standardization of Uveitis Nomenclature (SUN) scale
Proportion of eyes with absence of anterior chamber (AC) cells (score of 0) as measured by the Standardization of Uveitis Nomenclature (SUN) scale
Measured: From baseline through month 6
Time to resolution of anterior chamber (AC) cells and/or AC flare
Time to resolution of anterior chamber (AC) cells and/or AC flare
Measured: From baseline through month 6
Proportion of eyes with absence of pain as measured by pain scale of 1-10 (pain score of 0 = absence)
Proportion of eyes with absence of pain as measured by pain scale of 1-10 (pain score of 0 = absence)
Measured: From baseline through month 6
Number of patient call backs to medical staff regarding post-operative management of pain or medication management/dosing inquiry as documented by Electronic Health Record (E.H.R.).
Number of patient call backs to medical staff regarding post-operative management of pain or medication management/dosing inquiry as documented by Electronic Health Record (E.H.R.).
Measured: From baseline through month 6
Incidence and severity of adverse events
Incidence and severity of adverse events
Measured: From baseline through month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Glaucoma Following 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brian Jerkins, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Sponsor-investigator, Brian Jerkins, MD, University of Tennessee
- Investigators
- Brian Jerkins, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05116345
- Sponsor's protocol ID
- The DEXTenSiVe Study
- Acronym
- DEXTenSiVe
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2021
- Last updated
- 11 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Okeke CO, Quigley HA, Jampel HD, Ying GS, Plyler RJ, Jiang Y, Friedman DS. Adherence with topical glaucoma medication monitored electronically the Travatan Dosing Aid study. Ophthalmology. 2009 Feb;116(2):191-9. doi: 10.1016/j.ophtha.2008.09.004. Epub 2008 Dec 12.
PubMed 19084273Lee A, Blair HA. Correction to: Dexamethasone Intracanalicular Insert: A Review in Treating Post-Surgical Ocular Pain and Inflammation. Drugs. 2020 Aug;80(12):1265. doi: 10.1007/s40265-020-01366-0.
PubMed 32700064
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures
- ClinicalTrials.gov ID
- NCT05116345
- Acronym / sponsor ID
- DEXTenSiVe / The DEXTenSiVe Study
- Conditions
- Glaucoma Following Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Brian Jerkins, MDUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 11 Nov 2021 (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 is a prospective, comparative, open-label, single-center, randomized, investigator-sponsored clinical study and seeks to investigate clinical outcomes with standard of care and high dose DEXTENZA treatment compared to standard of care topical dexamethasone in patients undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, and Ahmed Valve surgery. Patients will be followed through 6 months. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, eyes of n=30 patients will be randomized to one of the following two groups (n=15per group) and followed from Baseline through Month 6.
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: DEXTENZAa single intracanalicular dexamethasone (0.4 mg) insert |
| Topical Dexamethasone Treatment | Active comparator | Drug: Topical DexamethasoneStandard of care topical dexamethasone treatment through Month 2 dosing and tapering following: 6x/day week 1 4x/day weeks 2-4 2x/day weeks 5-8 Day of surgery dexamethasone ointment and patch will be applied post-surgically for overnight treatment and removed at post-operative day 1 visit in Group B eyes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Able to provide signed written consent prior to participation in any study-related procedures
- Patient is diagnosed with glaucoma and undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, or Ahmed Valve surgery
Key exclusion criteria (8 listed)
- Have used topical corticosteroid treatment up to 48 hours prior to the baseline visit
- Have used oral corticosteroid within the past 14 days prior to baseline visit (Patients using stable doses of inhaled corticosteroids for 30 days prior to baseline visit can be included in the study)
- Have received intravitreal or sub-Tenon corticosteroid treatment prior to baseline visit or Ozurdex ® in the study eye within the 6 months prior to the baseline visit
- Are currently using prescribed nonsteroidal anti-inflammatory agents or prescribed immunosuppressive agents, unless the dose has been stable for the last 6 weeks and no change in dosing is anticipated for the duration of the study
- Are pregnant or lactating female, or female of childbearing age using inadequate birth control method
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 |
|---|---|---|
| DEXTENZAAlso: Dexamethasone (0.4mg) InsertIntracanalicular Dexamethasone ophthalmic insert (0.4mg) | Drug | DEXTENZA |
| Topical Dexamethasonetopical dexamethasone drops | Drug | Topical Dexamethasone Treatment |
Primary outcome
Mean change in intraocular pressure (IOP)
Time frame: From baseline through month 6
mean change in intraocular pressure (IOP) from day of surgery and proportion of eyes requiring additional topical dexamethasone or anti-metabolite therapy over time
8 secondary outcomes
Mean change in best corrected visual acuity (BCVA)
Time frame: From baseline through month 6
Mean change in Visual Field (MD)
Time frame: From baseline through month 6
Conjunctival healing outcomes as defined by proportion of eyes requiring needling intervention associated with scar/fibrin development
Time frame: From baseline through month 6
Proportion of eyes with absence of anterior chamber (AC) cells (score of 0) as measured by the Standardization of Uveitis Nomenclature (SUN) scale
Time frame: From baseline through month 6
Time to resolution of anterior chamber (AC) cells and/or AC flare
Time frame: From baseline through month 6
Proportion of eyes with absence of pain as measured by pain scale of 1-10 (pain score of 0 = absence)
Time frame: From baseline through month 6
Number of patient call backs to medical staff regarding post-operative management of pain or medication management/dosing inquiry as documented by Electronic Health Record (E.H.R.).
Time frame: From baseline through month 6
Incidence and severity of adverse events
Time frame: From baseline through month 6
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2021.
- Background: PubMed 19084273Okeke CO, Quigley HA, Jampel HD, Ying GS, Plyler RJ, Jiang Y, Friedman DS. Adherence with topical glaucoma medication monitored electronically the Travatan Dosing Aid study. Ophthalmology. 2009 Feb;116(2):191-9. doi: 10.1016/j.ophtha.2008.09.004. Epub 2008 Dec 12.
- Background: PubMed 32700064Lee A, Blair HA. Correction to: Dexamethasone Intracanalicular Insert: A Review in Treating Post-Surgical Ocular Pain and Inflammation. Drugs. 2020 Aug;80(12):1265. doi: 10.1007/s40265-020-01366-0.
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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.
Brian Jerkins, MD principal investigator
University of Tennessee
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 and Topical Dexamethasone in people with Glaucoma Following Surgery, run by Brian Jerkins, 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 2 inclusion and 8 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 11 Nov 2021. 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 Brian Jerkins, MD (901-338-1022, bjerkins@uthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in intraocular pressure (IOP) (time frame: From baseline through month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05116345, which also lists 2 linked publications.
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 Nov 2021.