Travoprost Intraocular Implant in Conjunction With Catara... | NCT06061718

Studies
Travoprost Intraocular Implant in Conjunction With Cataract Surgery

NCT06061718

Sponsor

Glaukos Corporation

Status

Unknown status

Last Update Posted

Jun 3, 2024Actual

Enrollment

60Actual

Phase

Phase 3

Conditions

Open Angle Glaucoma
Ocular Hypertension

Interventions

iDose TR

Countries

Armenia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 11, 2023Actual

Primary Completion Date

Mar 18, 2024Actual

Completion Date

Dec 20, 2024Estimated

First Submitted Date

Sep 25, 2023

First Submission Date that Met QC Criteria

Sep 25, 2023

First Posted Date

Sep 29, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 30, 2024

Last Update Posted Date

Jun 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Subjects with cataract requiring extraction and who have open-angle glaucoma or ocular hypertension will undergo screening and washout from IOP-lowering medication, if applicable. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria and who undergo successful cataract extraction with implantation of a posterior chamber intraocular lens (PC-IOL) will receive a travoprost intraocular implant and followed up for 12 months.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
iDose TR	Experimental	Travoprost Intraocular Implant administered intracamerally in the study eye at the Day 1 Visit following successful cataract surgery	Drug: iDose TR

Interventions

Name	Type	Description	Arm Group Labels	Other Names
iDose TR	Drug	anchored intracameral implant containing travoprost	iDose TR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in mean diurnal IOP	Mean diurnal IOP at the Month 3 Visit minus the mean diurnal IOP at the Baseline Visit	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

clinically significant age-related cataract eligible for phacoemulsification in the study eye
open-angle glaucoma or ocular hypertension in the study eye
successful, uncomplicated cataract surgery using small incision phacoemulsification cataract surgery and insertion of a foldable posterior chamber IOL

Exclusion Criteria:

unmedicated (washed out) IOP of >36 mmHg in the study eye
hypersensitivity to travoprost or any other components of the travoprost intraocular implant
vertical cup/disc ratio > 0.8 in the study eye
best spectacle corrected visual acuity of worse than 20/80 in the fellow eye
any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Study Director	Glaukos Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Glaukos Clinical Study Site		Yerevan			Armenia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39959854	Derived	Singh IP, Voskanyan LA, Barber KM, Burden JH, Connolly L, Katz LJ, Usner DW, Kothe AC, Navratil T. Safety and efficacy of travoprost intracameral implant administered in combination with cataract surgery. Ther Adv Ophthalmol. 2025 Feb 14;17:25158414241310275. doi: 10.1177/25158414241310275. eCollection 2025 Jan-Dec.

ID	Term
D005902	Glaucoma, Open-Angle
D009798	Ocular Hypertension

ID	Term
D005901	Glaucoma
D005128	Eye Diseases