DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures
NCT ID: NCT05116345
Last Updated: 2021-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
30 participants
INTERVENTIONAL
2021-11-30
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DEXTENZA
a single intracanalicular dexamethasone (0.4 mg) insert
DEXTENZA
Intracanalicular Dexamethasone ophthalmic insert (0.4mg)
Topical Dexamethasone Treatment
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.
Topical Dexamethasone
topical dexamethasone drops
Interventions
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DEXTENZA
Intracanalicular Dexamethasone ophthalmic insert (0.4mg)
Topical Dexamethasone
topical dexamethasone drops
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient is diagnosed with glaucoma and undergoing trabeculectomy, trabeculectomy Ex-PRESS, Xen Gel stent, or Ahmed Valve surgery
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Ocular Therapeutix, Inc.
INDUSTRY
Brian Jerkins, MD
OTHER
Responsible Party
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Brian Jerkins, MD
Assistant Professor
Principal Investigators
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Brian Jerkins, MD
Role: PRINCIPAL_INVESTIGATOR
University of Tennessee
Locations
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Hamilton Eye Institute
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Brian Jerkins, MD
Role: primary
Breia N. Dooley, MA
Role: backup
References
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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.
Lee 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.
Other Identifiers
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The DEXTenSiVe Study
Identifier Type: -
Identifier Source: org_study_id