Back to resultsTravoprost Intraocular Implant in Conjunction With Cataract Surgery
Primary Purpose
Open Angle Glaucoma, Ocular Hypertension
Status
Recruiting
Phase
Phase 3
Locations
Armenia
Study Type
Interventional
Intervention
iDose TR
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma
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
Sites / Locations
- Glaukos Clinical Study SiteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
iDose TR
Arm Description
Travoprost Intraocular Implant administered intracamerally in the study eye at the Day 1 Visit following successful cataract surgery
Outcomes
Primary Outcome Measures
Change from baseline in mean diurnal IOP
Mean diurnal IOP at the Month 3 Visit minus the mean diurnal IOP at the Baseline Visit
Secondary Outcome Measures
Full Information
NCT ID
NCT06061718
First Posted
September 25, 2023
Last Updated
September 25, 2023
Sponsor
Glaukos Corporation
1. Study Identification
Unique Protocol Identification Number
NCT06061718
Brief Title
Travoprost Intraocular Implant in Conjunction With Cataract Surgery
Official Title
Multicenter, Open-label, Single-arm Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iDose TR
Arm Type
Experimental
Arm Description
Travoprost Intraocular Implant administered intracamerally in the study eye at the Day 1 Visit following successful cataract surgery
Intervention Type
Drug
Intervention Name(s)
iDose TR
Other Intervention Name(s)
travoprost intraocular implant
Intervention Description
anchored intracameral implant containing travoprost
Primary Outcome Measure Information:
Title
Change from baseline in mean diurnal IOP
Description
Mean diurnal IOP at the Month 3 Visit minus the mean diurnal IOP at the Baseline Visit
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
949-481-8076
Email
idose@glaukos.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Glaukos Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Glaukos Clinical Study Site
City
Yerevan
Country
Armenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Study Director
Phone
949-481-8076
Email
idose@Glaukos.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Travoprost Intraocular Implant in Conjunction With Cataract Surgery
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