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Device

Travoprost Implant + iStent vs. iStent Alone for Glaucoma

Phase 3

Recruiting

Research Sponsored by Glaukos Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of open-angle glaucoma or ocular hypertension

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial tests if a trabecular bypass system and an intraocular implant can reduce eye pressure in adults with glaucoma.

Who is the study for?

This trial is for adults with open-angle glaucoma or ocular hypertension who have had the iStent infinite system placed in their eye. They must not have an unmedicated eye pressure over 36 mmHg, be allergic to travoprost, have a high cup/disc ratio, poor vision worse than 20/80, or any other risky eye conditions.Check my eligibility

What is being tested?

The study tests if adding a travoprost intraocular implant after placing the iStent infinite device helps lower eye pressure better than the stent alone. Participants are randomly chosen to get either the real implant or a pretend procedure and will be monitored for one year.See study design

What are the potential side effects?

Possible side effects of the travoprost implant may include redness, discomfort in the eye, blurry vision, dry eyes or eyelash growth. The sham procedure might cause similar symptoms due to placebo effect.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with open-angle glaucoma or high eye pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

change from baseline in mean diurnal intraocular pressure (IOP)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: iDose TRExperimental Treatment2 Interventions

Travoprost Intraocular Implant in subjects who had successful iStent infinite placement

Group II: sham procedurePlacebo Group2 Interventions

Sham surgical procedure in subjects who had successful iStent infinite placement

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Glaukos CorporationLead Sponsor

65 Previous Clinical Trials

8,890 Total Patients Enrolled

Study DirectorStudy DirectorGlaukos Corporation

1,211 Previous Clinical Trials

489,122 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open recruitment opportunities for this clinical experiment?

"Data hosted on clinicaltrials.gov indicates that this research trial is actively recruiting participants, having been originally posted on September 14th 2023 and most recently edited on September 27th 2023."

Answered by AI

Has iDose TR acquired regulatory authorization from the Food and Drug Administration?

"Our team at Power ranks the safety of iDose TR a 3 due to its Phase 3 trial status, which implies there is evidence supporting both efficacy and safety."

Answered by AI

How many participants are engaged in this clinical trial?

"Affirmative. According to the clinicaltrials.gov platform, this medical trial is actively looking for participants and was recently updated on September 27th 2023. 150 individuals are sought from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone

2023. "Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06066645.

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