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

ConditionsGlaucoma, Open-angle Ocular Hypertension (OHT)Phacoemulsification Cataract Surgery

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age45+

SponsorGlaukos Corporation

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Active corneal inflammation or edema.

Retinal disorders not associated with glaucoma.

Trial design

Design model

Parallel

Treatments tested in this trial

iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
Combination product
iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery
Sham procedure in conjunction with cataract surgery
Procedure/Surgery
Sham procedure in conjunction with cataract surgery

Treatment groups

132 Participants

are divided into 2 treatment groups

Group A: iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgeryActive comparator 1 intervention

Group B: Sham procedure in conjunction with cataract surgerySham comparator 1 intervention

Trial outcomes

Primary outcomes

Change from baseline in mean diurnal IOP

Mean diurnal IOP at the Month 3 Visit minus mean diurnal IOP at the Baseline Visit

Time frame

3 Months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Glaukos Corporation

Lead sponsor

Source ClinicalTrials.gov

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