Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone
NCT06848946 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 132
Last updated 2026-01-21
Summary
This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone
Conditions
- Glaucoma, Open-angle
- Ocular Hypertension (OHT)
- Phacoemulsification Cataract Surgery
Interventions
- COMBINATION_PRODUCT
-
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
- PROCEDURE
-
Sham procedure in conjunction with cataract surgery
Sham procedure in conjunction with cataract surgery
Sponsors & Collaborators
-
Glaukos Corporation
lead INDUSTRY
Principal Investigators
-
Study Director · Glaukos Corporation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-01-13
- Primary Completion
- 2026-08-31
- Completion
- 2027-06-30
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Intracameral Mydriasis Versus Topical Mydriasis in Cataract Surgery
NCT00690222 ·Status: TERMINATED ·Phase: NA
-
Intraocular Steroid After Cataract Surgery Study
NCT00478764 ·Status: COMPLETED ·Phase: NA
-
A Bioequivalence Study to Compare the Pharmacokinetics (PK) Of Marketed Product TobraDex® To An Experimental Ophthalmic Sterile Ointment Containing Tobramycin And Dexamethasone In Aqueous Humor In Patients Undergoing Indicated Cataract Surgery
NCT02734459 ·Status: COMPLETED ·Phase: PHASE3
-
Outcomes of Intraoperative 5-Fluorouracil Versus Mitomycin C
NCT00346489 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Effectiveness of Drop-free Small Incision Cataract Surgery
NCT05248139 ·Status: UNKNOWN ·Phase: NA
-
OPEN-LABEL, MULTI-CENTER, PHASE 1b/2a CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND EFFICACY OF IONTOPHORETIC DEXAMETHASONE PHOSPHATE OPHTHALMIC SOLUTION IN PATIENTS HAVING UNDERGONE CATARACT SURGERY WITH IMPLANTATION OF A POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)
NCT02571556 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Diclofenac vs Dexamethasone in Combined Surgery
NCT00825864 ·Status: COMPLETED ·Phase: NA
-
Anti-inflammatory Therapy Following Selective Laser Trabeculoplasty
NCT00485108 ·Status: COMPLETED ·Phase: NA
-
Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOL
NCT01602068 ·Status: COMPLETED ·Phase: PHASE2
-
Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections
NCT02951351 ·Status: COMPLETED ·Phase: NA
-
A Study of TRS01 in Participants With Post-surgical Ocular Inflammation
NCT04222725 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)
NCT01023724 ·Status: COMPLETED ·Phase: PHASE4
-
Dropless vs. Standard Drops Contralateral Eye Study
NCT02515045 ·Status: COMPLETED ·Phase: PHASE4
-
Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-2)
NCT04249076 ·Status: COMPLETED ·Phase: PHASE3
-
Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-1)
NCT04246801 ·Status: COMPLETED ·Phase: PHASE3
-
Prednisolone Acetate Eye Drops for Pain Intervention in Second Eye Cataract Surgery
NCT06614348 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Trial Evaluating Patient Preference of Dropless vs Drops Post Cataract Surgery
NCT04205916 ·Status: RECRUITING ·Phase: PHASE4
-
2nd Study to Assess ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery
NCT03192150 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Anti-inflammatory Topical Prednisolone, Nepafenac and Ketorolac in Intra-operative Mydriasis in Facetectomies
NCT00865540 ·Status: UNKNOWN ·Phase: PHASE4
-
Efficacy of Topical Ketorolac Versus Placebo for Improving Visual Outcomes Following Multifocal IOL Implantation
NCT00433225 ·Status: COMPLETED ·Phase: PHASE4
-
Ocular Penetration of Topical Tacrolimus Eye Drops
NCT02794610 ·Status: UNKNOWN ·Phase: NA
-
Comparing Acular LS and Pred Forte in Reducing Post-selective Laser Trabeculoplasty Anterior Chamber Flare and Cells
NCT00478036 ·Status: TERMINATED ·Phase: NA
-
Sub-Tenon's Injection of Triamcinolone and Ciprofloxacin in a Controlled-Release System for Cataract Surgery
NCT00431028 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery
NCT00909324 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery
NCT02101359 ·Status: COMPLETED ·Phase: PHASE3