Clinical Trials Logo
  1. Home
  2. Open-Angle Glaucoma
  3. NCT02873806

Two Trabecular Micro-bypass Stents & Postoperative Travoprost to Treat Glaucoma Subjects on Two Hypotensive Agents

Open-angle Glaucoma Clinical Trial

Official title:
A Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medications (One a Prostaglandin) Treated With Two Trabecular Micro-bypass Stents (iStent Inject) and a Postoperative Topical Prostaglandin

Clinical Trial Summary

The study objective was to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma, washed out of two anti-glaucoma medications (one a Prostaglandin) prior to stent implantation.

Clinical Trial Description

The study design is as follows: - Prospective, single-arm study. - Subjects with open-angle glaucoma and medicated IOP > 18 mmHg and ≤ 30 mmHg. - Subjects on two topical ocular hypotensive medications (one a prostaglandin). - Implantation of two iStent inject devices (if IOP is < 6 mmHg, at any point during the postoperative follow-up, medication will not be prescribed or will be discontinued). - IOP will be measured by two (2) observers to minimize bias; observer 1 will look through the slit lamp and turn the dial with readings being masked, and observer 2 will document the IOP. - Follow-up through 60 months postoperative (or up to 61 months if subject needs to undergo terminal washout). - Descriptive statistics will be tabulated. - Medical therapy considered necessary for the subject's welfare can be implemented at any time during the study at the investigator's discretion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02873806
Study type Interventional
Source Glaukos Corporation
Contact
Status Completed
Phase Phase 4
Start date March 2013
Completion date November 8, 2019
View Details
See also
  Status Clinical Trial Phase
Completed NCT01157364 - Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension Phase 1/Phase 2
Completed NCT02558374 - Double-masked Study of Netarsudil (AR-13324) Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension Phase 3
Completed NCT01456390 - Open-Angle Glaucoma Subjects With One Prior Trabeculectomy Treated Concurrently With One Suprachoroidal Stent and Two Trabecular Micro-bypass Stents N/A
Completed NCT01443988 - Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent)or Travoprost Phase 4
Completed NCT01444040 - Subjects With Open-angle Glaucoma, Pseudoexfoliative Glaucoma, or Ocular Hypertension Naïve to Medical and Surgical Therapy, Treated With Two Trabecular Micro-bypass Stents (iStent Inject) or Travoprost Phase 4
Completed NCT01415401 - Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada Phase 4
Completed NCT01426867 - A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2% Phase 2
Completed NCT01487655 - Waveform Analysis of the Doppler Curve of Ophthalmic Arteries in Glaucoma Patients N/A
Completed NCT01444105 - Open-angle Glaucoma Subjects on One Ocular Hypotensive Medication Randomized to Treatment With Two Trabecular Micro-bypass Stents or Selective Laser Trabeculoplasty N/A
Completed NCT01340014 - Patient Preference Comparison of AZARGA Versus COSOPT Phase 4
Completed NCT01455467 - Open-angle Glaucoma Subjects on One Topical Hypotensive Medication Randomized to Treatment With One or Two Trabecular Micro-bypass Stents in Conjunction With Cataract Surgery N/A
Completed NCT00759239 - Phase IV Randomised Double-masked Clinical Trial: Assessing Morning Versus Evening Dosing of a Fixed Dose Combination of Travoprost 0.004% / Timolol Maleate 0.5% in Patients With Primary Open-angle Glaucoma or Ocular Hypertension Phase 4
Completed NCT00397241 - 24-hour Study of Dorzolamide/Timolol and Latanoprost/Timolol Fixed Combinations Phase 4
Completed NCT00273481 - Cosopt Versus Xalacom Phase 4
Completed NCT00918346 - Pharmacodynamics of Tafluprost 0.0015% Eye Drops: a Comparison Between the Preserved and Unpreserved Formulation Phase 3
Completed NCT00716742 - Safety and Efficacy Study of Bimatoprost, Latanoprost, and Travoprost in Patients With Elevated Intraocular Pressure (IOP) and Open-angle Glaucoma (OAG) N/A
Completed NCT02558400 - Double-masked Study of PG324 Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3
Withdrawn NCT03648229 - African Glaucoma Laser Trial Phase 4
Completed NCT01978600 - Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension Phase 4
Completed NCT01699464 - A Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months Phase 2