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| Name | Class |
|---|---|
| Ocular Therapeutix, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DEXTENZA | Experimental | a single intracanalicular dexamethasone (0.4 mg) insert |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DEXTENZA | Drug | Intracanalicular Dexamethasone ophthalmic insert (0.4mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline through month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in best corrected visual acuity (BCVA) | Mean change in BCVA using Snellen eye charts | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brian Jerkins, MD | Contact | 901-338-1022 | bjerkins@uthsc.edu | |
| Breia N. Dooley, MA | Contact | 901-448-3269 | bdooley3@uthsc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brian Jerkins, MD | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Eye Institute | Memphis | Tennessee | 38103 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19084273 | Background | 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. | |
| 32700064 | Background | 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. |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| D016254 | Mutagenesis, Insertional |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Topical Dexamethasone | Drug | topical dexamethasone drops |
|
| 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 | 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 | 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 | 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) | 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.). | From baseline through month 6 |
| Incidence and severity of adverse events | Incidence and severity of adverse events | From baseline through month 6 |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D015202 | Protein Engineering |
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D009154 | Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |