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

NCT04360174 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: CLN-Protocol-0045
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 5

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.

Conditions

Ocular Hypertension; Open Angle Glaucoma

Outcome Measures

Primary Outcomes (2)

• Ocular Treatment Emergent Adverse Events

  All adverse events will be captured throughout the study

  Through study completion, 6 months

• Efficacy Outcome

  IOP measurements at 8 am

  Diurnal IOP [12 Week Visit]

Study Arms (4)

OTX-TIC-Cohort 1

EXPERIMENTAL

15 µg (formulation1) implant

Drug: OTX-TIC

OTX-TIC-Cohort 2

EXPERIMENTAL

26 µg (formulation1) implant

Drug: OTX-TIC

OTX-TIC-Cohort 3

EXPERIMENTAL

15 µg (formulation 2) implant

Drug: OTX-TIC

OTX-TIC-Cohort 4

EXPERIMENTAL

5 µg (formulation 3) implant

Drug: OTX-TIC

Interventions

OTX-TIC DRUG

OTX-TIC implant is injection in the anterior chamber of the eye

OTX-TIC-Cohort 1; OTX-TIC-Cohort 2; OTX-TIC-Cohort 3; OTX-TIC-Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ocular Therapeutix, Inc.: lead

Study Sites (5)

Ocular Therapeutix, Inc.

Petaluma, California, 94954, United States

Location

Ocular Therapeutix, Inc.

Torrance, California, 90505, United States

Location

Ocular Therapeutix, Inc

Roswell, Georgia, 30076, United States

Location

Ocular Therapeutix, Inc.

Austin, Texas, 78731, United States

Location

Ocular Therapeutix, Inc.

Racine, Wisconsin, 53405, United States

Location

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Ocular Therapeutix

clinicalaffairs@ocutx.com

7813574000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 studies

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: April 24, 2020
• Study Start: April 25, 2018
• Primary Completion: May 24, 2021
• Study Completion: May 24, 2021
• Last Updated: October 1, 2024
• Results First Posted: October 1, 2024

Record last verified: 2024-09

Locations

US (5)