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Recruiting NCT06848946

Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone

Phase IV Interventional Glaucoma, Open-angle Ocular Hypertension (OHT) Phacoemulsification Cataract Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery, Sham procedure in conjunction with cataract surgery.
Who it may be relevant to
Registry conditions: Glaucoma, Open-angle, Ocular Hypertension (OHT), Phacoemulsification Cataract Surgery. Basic parameters: from 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicenter, Randomized, Double-masked, Parallel Group Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intracameral Implant) in Conjunction With Cataract Surgery vs. Cataract Surgery Alone

Overview

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

Detailed description

This is a Phase 4 randomized, double-masked, parallel group trial designed to evaluate the safety and IOP-lowering efficacy of administering iDose TR (travoprost intracameral implant 75 mcg) in conjunction with uncomplicated cataract surgery (phacoemulsification with a posterior chamber intraocular lens) compared to uncomplicated cataract surgery alone, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

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

Primary outcome measures

  • Change from baseline in mean diurnal IOP [Time frame: 3 Months]

Eligibility criteria

Inclusion criteria

  • Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye.
  • OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)

Exclusion criteria

  • Active corneal inflammation or edema.
  • Retinal disorders not associated with glaucoma.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Glaukos Investigator Site — Kenosha

Identifiers

NCT: NCT06848946 · GLK-101-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗