Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery
Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Prednisolone Acetate 1%.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Cataract surgery gtt regimen per SOC | Active Comparator | Following cataract surgery (without Dextenza 0.4mg insert) patients will receive: Prednisolone Acetate 1% QID X 2 Weeks, then BID x 2 weeks and stop / Prolensa 0.07% QD X 4 Weeks and stop. |
|
| Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen | Experimental | Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza 0.4Mg Ophthalmic Insert | Drug | DEXTENZA 0.4Mg Ophthalmic Insert is a corticosteroid (to decrease inflammation) intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in anterior chamber inflammation (Cell and Flare) scores | Measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1. 0-4 score scale, higher scores mean a worse outcome. 0-1 Absent, 1-2 Mild, 2-3 Moderate, 4 Severe. | Assessed on Days 1,7,30,90 |
| Mean change in pain score | Measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible, higher scores mean a worse outcome. 0-10 Absent, 11-30 Mild, 31-70 Moderate, 71-100 Severe. | Assessed on Day 1,7, 30 and 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Visual outcome (Best Corrected Visual Acuity) | Measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart. 0-70 letter read score, higher scores mean a better outcome. | Assessed on Day 1,7, 30 and 90 |
| Absence of CME (Cystoid Macular Edema) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint: corneal or retinal edema | Measured by slit lamp examination and supporting imaging and testing such as Pachymetry measured in micrometer (μm) or Macular OCT (Optical Coherence Tomography) measured in microns (μ). Higher scores (in comparison to preop measurements) mean a worse outcome. | Assessed throughout 90-day study period |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicole R Fram, M.D. | Advanced Vision Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Vision Care | Los Angeles | California | 90067 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14078871 | Background | ARMALY MF. EFFECT OF CORTICOSTEROIDS ON INTRAOCULAR PRESSURE AND FLUID DYNAMICS. II. THE EFFECT OF DEXAMETHASONE IN THE GLAUCOMATOUS EYE. Arch Ophthalmol. 1963 Oct;70:492-9. doi: 10.1001/archopht.1963.00960050494011. No abstract available. | |
| 30689622 | Background | Patel SB, Reddy NK, He YG. TOXIC POSTERIOR SEGMENT SYNDROME AFTER DROPLESS CATARACT SURGERY WITH COMPOUNDED TRIAMCINOLONE-MOXIFLOXACIN. Retina. 2020 Mar;40(3):446-455. doi: 10.1097/IAE.0000000000002450. |
| Label | URL |
|---|---|
| Dextenza \[package insert\]. Bedford, MA: Ocular Therapeutix, Inc; 2019 | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In patient who undergo cataract surgery, subjects will be randomized to 2 arms and be followed for a period of 3 months.
Arm 1- control group, 25 subjects will receive Prednisolone Acetate 1% QID x 2 weeks then BID x 2 weeks.
Arm 2 - study group, 25 subjects will receive Dextenza 0.4mg insert
Not provided
Not provided
Not provided
Not provided
|
|
| Prednisolone Acetate 1% Oph Susp | Drug | Prednisolone Acetate 1% is a corticosteroid (to decrease inflammation) and being used as a topical drop after cataract surgery per Standard Of Care. |
|
| Prolensa 0.07% Ophthalmic Solution | Drug | Prolensa 0.07% is a NSAID (to decrease inflammation, swelling and pain) and is being used as a topical drop after cataract surgery per Standard Of Care. |
|
Macular thickness measured by OCT (Optical Coherence Tomography) and compared to the preop measurements, higher scores (>over 50 microns) mean a worse outcome.
| Assessed on Day 90 |
| Mean change in corneal staining | measured by the National Eye Institute 0-4 score scale, higher scores mean a worse outcome. 0-1 Mild, 2-3 Moderate, 4 Severe. Total score 0-5 Mild, 6-15 Moderate, 16-20 Severe. | Assessed on Day 7, 30 and 90 |
| Safety endpoint: Signs of Rebound Iritis |
Measured by slit lamp examination and scored by SUN (Standardization on Uveitis Nomenclature) grading scale of Anterior chamber Cell and Flare presence. 0-4 score scale. Cell: 0-0.5 Absence, 1-2 Mild, 2-3 Moderate 4 Severe. Flare: 0-1 Absence, 2 Mild, 3 Moderate, 4 Severe. Higher scores mean a worse outcome. (specifically sub-grouped Blue vs. Brown eyed subjects) |
| Assessed throughout 90-day study period |
| Safety endpoint: Change in IOP (IntraOcular Pressure) initiating rescue medications | Measured by Applanation in millimeter Hg(Mercury), higher then 22mm Hg or lower then 10mm Hg mean a worse outcome and a need for rescue. | Assessed throughout 90-day study period |
| 37643045 | Background | Freire FS, Lang R, Abalem MF, Johnson MW. RETINAL DEPOSITS OF TRIAMCINOLONE-MOXIFLOXACIN AFTER DROPLESS CATARACT SURGERY. Retin Cases Brief Rep. 2023 Sep 1;17(5):577-580. doi: 10.1097/ICB.0000000000001243. |
| 16196117 | Background | Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057. |
| 35992569 | Background | Ibach MJ, Zimprich L, Wallin DD, Olevson C, Puls-Boever K, Thompson V. In Clinic Optometrist Insertion of Dextenza (Dexamethasone Ophthalmic Insert 0.4mg) Prior to Cataract Surgery: The PREPARE Study. Clin Ophthalmol. 2022 Aug 13;16:2609-2615. doi: 10.2147/OPTH.S374405. eCollection 2022. |
| 34506241 | Background | Ibach MJ, Shafer BM, Wallin DD, Puls-Boever KR, Thompson VM, Berdahl JP. The Effectiveness and Safety of Dextenza 0.4 mg for the Treatment of Postoperative Inflammation and Pain in Patients After Photorefractive Keratectomy: The RESTORE Trial. J Refract Surg. 2021 Sep;37(9):590-594. doi: 10.3928/1081597X-20210610-05. Epub 2021 Sep 1. |
| 39051020 | Background | Alsetri H, Fram N, Shiler O. Evaluating a Sustained-Release Dexamethasone Insert as Adjunctive Therapy for Inflammation and Pain Post-Corneal Transplantation. Clin Ophthalmol. 2024 Jul 16;18:2083-2091. doi: 10.2147/OPTH.S466118. eCollection 2024. |
| 36532822 | Background | Fram N, Alsetri H, Shiler O, Paterno PJ, Cabang J. Retrospective Study of a Sustained-Release Intracanalicular Dexamethasone Insert for Treatment of Ocular Inflammation After Cataract and Corneal Surgery. Clin Ophthalmol. 2022 Dec 10;16:4065-4074. doi: 10.2147/OPTH.S386702. eCollection 2022. |
| 39089352 | Background | Shapiro JN, Armenti ST, Levine H, Hood CT, Mian SI. Dexamethasone Intracanalicular Insert versus Standard Topical Steroids for the Prophylaxis of Inflammation after Cataract Surgery. Am J Ophthalmol. 2024 Dec;268:174-180. doi: 10.1016/j.ajo.2024.07.030. Epub 2024 Jul 31. |
| 30367938 | Background | Tyson SL, Bafna S, Gira JP, Goldberg DF, Jones JJ, Jones MP, Kim JK, Martel JM, Nordlund ML, Piovanetti-Perez IK, Singh IP, Metzinger JL, Mulani D, Sane S, Talamo JH, Goldstein MH; Dextenza Study Group. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019 Feb;45(2):204-212. doi: 10.1016/j.jcrs.2018.09.023. Epub 2018 Oct 24. |
| 26703279 | Background | Walters T, Endl M, Elmer TR, Levenson J, Majmudar P, Masket S. Sustained-release dexamethasone for the treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2015 Oct;41(10):2049-59. doi: 10.1016/j.jcrs.2015.11.005. |
| 37600148 | Background | Donnenfeld ED, Hovanesian JA, Malik AG, Wong A. A Randomized, Prospective, Observer-Masked Study Comparing Dropless Treatment Regimen Using Intracanalicular Dexamethasone Insert, Intracameral Ketorolac, and Intracameral Moxifloxacin versus Conventional Topical Therapy to Control Postoperative Pain and Inflammation in Cataract Surgery. Clin Ophthalmol. 2023 Aug 15;17:2349-2356. doi: 10.2147/OPTH.S422502. eCollection 2023. |
| 30850125 | Background | Nassiri S, Hwang FS, Kim J, LeClair B, Yoon E, Pham M, Rauser ME. Comparative analysis of intravitreal triamcinolone acetonide-moxifloxacin versus standard perioperative eyedrops in cataract surgery. J Cataract Refract Surg. 2019 Jun;45(6):760-765. doi: 10.1016/j.jcrs.2018.12.019. Epub 2019 Mar 6. |
| 19668589 | Background | Chang DT, Herceg MC, Bilonick RA, Camejo L, Schuman JS, Noecker RJ. Intracameral dexamethasone reduces inflammation on the first postoperative day after cataract surgery in eyes with and without glaucoma. Clin Ophthalmol. 2009;3:345-55. doi: 10.2147/opth.s5730. Epub 2009 Jun 2. |
| 35903174 | Background | Kuriakose RK, Cho S, Nassiri S, Hwang FS. Comparative Outcomes of Standard Perioperative Eye Drops, Intravitreal Triamcinolone Acetonide-Moxifloxacin, and Intracameral Dexamethasone-Moxifloxacin-Ketorolac in Cataract Surgery. J Ophthalmol. 2022 Jul 19;2022:4857696. doi: 10.1155/2022/4857696. eCollection 2022. |
| 35534685 | Background | Miura M, Inomata T, Nakamura M, Sung J, Nagino K, Midorikawa-Inomata A, Zhu J, Fujimoto K, Okumura Y, Fujio K, Hirosawa K, Akasaki Y, Kuwahara M, Eguchi A, Shokirova H, Murakami A. Prevalence and Characteristics of Dry Eye Disease After Cataract Surgery: A Systematic Review and Meta-Analysis. Ophthalmol Ther. 2022 Aug;11(4):1309-1332. doi: 10.1007/s40123-022-00513-y. Epub 2022 May 9. |
| 25028534 | Background | Quintana NE, Allocco AR, Ponce JA, Magurno MG. Non steroidal anti-inflammatory drugs in the prevention of cystoid macular edema after uneventful cataract surgery. Clin Ophthalmol. 2014 Jun 25;8:1209-12. doi: 10.2147/OPTH.S61604. eCollection 2014. |
| 19403110 | Background | Belair ML, Kim SJ, Thorne JE, Dunn JP, Kedhar SR, Brown DM, Jabs DA. Incidence of cystoid macular edema after cataract surgery in patients with and without uveitis using optical coherence tomography. Am J Ophthalmol. 2009 Jul;148(1):128-35.e2. doi: 10.1016/j.ajo.2009.02.029. Epub 2009 Apr 29. |
| 9279670 | Background | Pande MV, Spalton DJ, Kerr-Muir MG, Marshall J. Postoperative inflammatory response to phacoemulsification and extracapsular cataract surgery: aqueous flare and cells. J Cataract Refract Surg. 1996;22 Suppl 1:770-4. doi: 10.1016/s0886-3350(96)80160-x. |
| 25248295 | Background | An JA, Kasner O, Samek DA, Levesque V. Evaluation of eyedrop administration by inexperienced patients after cataract surgery. J Cataract Refract Surg. 2014 Nov;40(11):1857-61. doi: 10.1016/j.jcrs.2014.02.037. Epub 2014 Sep 22. |
| ID | Term |
|---|---|
| D015715 | Corneal Edema |
| D058447 | Eye Pain |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D005132 | Eye Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| C009935 | prednisolone acetate |
| C053083 | bromfenac |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| 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 |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
Not provided
Not provided