CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension

Sponsor

Ocular Therapeutix, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04360174

Collaborator

(none)

Enrollment

Locations

Arms

42.3

Anticipated Duration (Months)

3.8

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension Open Angle Glaucoma	Drug: OTX-TIC	Phase 1

Detailed Description

This is a prospective, multicenter, open label study, to evaluate the safety, tolerability and efficacy of OTX-TIC intracameral implant in subjects with primary open-angle glaucoma or ocular hypertension. The subjects will be followed for approximately 7 months (one-month washout and 6 months follow-up after injected of the OTX-TIC implant).

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Sequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studiesSequential: Groups of participants are assigned to receive interventions based on prior milestones being reached in the study, such as in some dose escalation and adaptive design studies

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of OTX-TIC (Travoprost) Implant in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

Actual Study Start Date :

Apr 25, 2018

Actual Primary Completion Date :

May 15, 2021

Anticipated Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OTX-TIC-Cohort 1 15 µg (formulation1) implant	Drug: OTX-TIC OTX-TIC implant is injection in the anterior chamber of the eye
Experimental: OTX-TIC-Cohort 2 26 µg (formulation1) implant	Drug: OTX-TIC OTX-TIC implant is injection in the anterior chamber of the eye
Experimental: OTX-TIC-Cohort 3 15 µg (formulation 2) implant	Drug: OTX-TIC OTX-TIC implant is injection in the anterior chamber of the eye
Experimental: OTX-TIC-Cohort 4 5 µg (formulation 3) implant	Drug: OTX-TIC OTX-TIC implant is injection in the anterior chamber of the eye

Outcome Measures

Primary Outcome Measures

Incidence of treatment emergent adverse events for each subject [Through study completion, 6 months]
All adverse events will be captured throughout the study
Efficacy outcome [Diurnal IOP [Time Frame: 2 Week Visit]]
IOP measurements at 8 am, 10 am, and 4 pm
Efficacy outcome [Diurnal IOP [ 6 Week Visit]]
IOP measurements at 8 am, 10 am, and 4 pm
Efficacy outcome [Diurnal IOP [12 Week Visit]]
IOP measurements at 8 am, 10 am, and 4 pm
Efficacy outcome [Diurnal IOP [4 Months Visit]]
IOP measurements at 8 am, 10 am, and 4 pm
Efficacy outcome [Diurnal IOP [6 Months Visit]]
IOP measurements at 8 am, 10 am, and 4 pm

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have a documented diagnosis of ocular hypertension or primary open-angle glaucoma
Have IOP that is currently controlled as assessed by the Investigator
Have open, normal appearing anterior chamber angles as determined by gonioscopy

Exclusion Criteria:

Have closed angle glaucoma, narrow angle glaucoma, pseudoexfoliation syndrome, pseudoexfoliation glaucoma, pigment dispersion or pigmentary glaucoma, glaucoma diagnosis prior to 15 years of age, inflammatory, neovascular or other secondary
Have a known or suspected allergy and/or hypersensitivity to a prostaglandin (i.e. travoprost), fluorescein or to any component of the study products

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ocular Therapeutix, Inc.	Petaluma	California	United States	94954
2	Ocular Therapeutix, Inc.	Torrance	California	United States	90505
3	Ocular Therapeutix, Inc	Roswell	Georgia	United States	30076
4	Ocular Therapeutix, Inc.	Austin	Texas	United States	78731
5	Ocular Therapeutix, Inc.	Racine	Wisconsin	United States	53405

Sponsors and Collaborators

Ocular Therapeutix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ocular Therapeutix, Inc.

ClinicalTrials.gov Identifier:

NCT04360174

Other Study ID Numbers:

CLN-Protocol-0045

First Posted:

Apr 24, 2020

Last Update Posted:

Jun 10, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2021