NCT04962009

Safety and Intraocular Lowering Effect of Delivery of Travoprost Evolute® in Subjects With Elevated Intraocular Pressure

A 90-Day, Open-Label, Multi-Site, Pilot Study Evaluating the Safety and Intraocular Lowering Effect of Delivering Travoprost Using a Punctal Plug Delivery System (Evolute®) in Subjects With Elevated Intraocular Pressure

• Status: Completed
• Phase: —
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Mati Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot, open-label, multi-center clinical study. Each potential subject that has met all screening inclusion/exclusion criteria will undergo a six-week washout phase where they will discontinue the use of their topical hypotensive medication. After the six-week washout, each potential subject will return for a baseline visit. Investigators will verify that a potential subject has discontinued the use of their topical hypotensive medication(s) and all their prohibited systemic medications for the last 6 weeks. In addition, each subject will have discontinued the use of all other ocular drops, gels or ointments 24 hours prior to the visit (Visit 2) and continues to meet all screening and washout criteria. After completing the baseline examination, each potential subject that meet all baseline inclusion/exclusion for the treatment phase of the study will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.

Detailed description

This is a pilot, open-label, multi-center clinical study. Each potential subject that has given HIPAA and informed consent and has meet all screening inclusion/exclusion criteria will undergo a six-week washout phase where they will discontinue the use of their topical hypotensive medication. In addition, during the washout phase, each potential study subject will also discontinue the use of all prohibited systemic medications. After the six-week washout, each potential subject will return for a baseline visit (Visit 2). Investigators will verify that a potential subject has discontinued the use of their topical hypotensive medication(s) and all their prohibited systemic medications for the last 6 weeks. In addition, each subject will have discontinued the use of all other ocular drops, gels or ointments 24 hours prior to the visit (Visit 2) and continues to meet all screening and washout criteria. After completing the baseline examination, each potential subject that meet all baseline inclusion/exclusion for the treatment phase of the study will have his/her lower puncta of each eye inserted with a Travoprost Punctal Plug Delivery System (Evolute®). Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.

Conditions

• Elevated Intraocular Pressure (IOP)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Travoprost Evolute® (Travoprost Punctal Plug Delivery System), 166 ug	Each subject will have his/her lower puncta of each eye inserted with a Travoprost Evolute®. Each study subject will be instructed to return to the investigator's office the next day, 7, 28, 60 and 90-days after the insertion of their plugs for follow-up examinations.

Timeline

• Start date: 2021-09-08
• Primary completion: 2022-07-15
• Completion: 2022-07-15
• First posted: 2021-07-14
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

1 site across 1 country: United States