Introduction <p>The purpose of this analysis was to assess the safety outcomes of a subgroup of patients who received a travoprost intracameral implant in an office-based surgery setting from one of the phase 3 registration trials, GC-012, for the implant.</p> Methods <p>Adult patients with open-angle glaucoma or ocular hypertension on 0 to 3 pre-study intraocular pressure (IOP)-lowering medications underwent a washout period (if applicable). Patients who qualified based on having an unmedicated mean diurnal IOP of 21 mmHg or greater and an IOP of 36 mmHg or less at each of the diurnal timepoints received a travoprost intracameral implant and were followed for safety outcomes at eight visits over a 12-month period. Safety evaluations included adverse events, slit-lamp examination, gonioscopy, pachymetry, dilated fundus examination, specular microscopy, perimetry, and best-corrected visual acuity.</p> Results <p>A total of 37 patients received a travoprost intracameral implant in an office-based surgery setting. Administration of the implant was successful in 100% of patients. There were no serious ocular adverse events or ocular infections in patients administered the implant.</p> Conclusions <p>This subgroup analysis demonstrated that administration of the travoprost intracameral implant in an office-based surgery setting was safe and well tolerated.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT03868124.</p>

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Administration of the Travoprost Intracameral Implant in an Office-Based Surgery Setting

  • Inder Paul Singh,
  • George R. Reiss,
  • Brian E. Flowers,
  • L. Jay Katz,
  • Dale W. Usner,
  • David Applegate,
  • Angela C. Kothe,
  • Tomas Navratil

摘要

Introduction

The purpose of this analysis was to assess the safety outcomes of a subgroup of patients who received a travoprost intracameral implant in an office-based surgery setting from one of the phase 3 registration trials, GC-012, for the implant.

Methods

Adult patients with open-angle glaucoma or ocular hypertension on 0 to 3 pre-study intraocular pressure (IOP)-lowering medications underwent a washout period (if applicable). Patients who qualified based on having an unmedicated mean diurnal IOP of 21 mmHg or greater and an IOP of 36 mmHg or less at each of the diurnal timepoints received a travoprost intracameral implant and were followed for safety outcomes at eight visits over a 12-month period. Safety evaluations included adverse events, slit-lamp examination, gonioscopy, pachymetry, dilated fundus examination, specular microscopy, perimetry, and best-corrected visual acuity.

Results

A total of 37 patients received a travoprost intracameral implant in an office-based surgery setting. Administration of the implant was successful in 100% of patients. There were no serious ocular adverse events or ocular infections in patients administered the implant.

Conclusions

This subgroup analysis demonstrated that administration of the travoprost intracameral implant in an office-based surgery setting was safe and well tolerated.

Trial Registration

ClinicalTrials.gov identifier, NCT03868124.