Study of the ETX-4143 2.0 Device in Subjects With Eye Pain

NCT06479382 | Completed DMC

• 1 other identifier: ETX4143-A002
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 4

Brief Summary

A prospective early-feasibility study to evaluate the safety and effectiveness of the ETX-4143 2.0 device. The device is intended to treat subjects with eye pain

Conditions

Eye Pain

Outcome Measures

Primary Outcomes (2)

• Reduction of eye pain

  Patient reported level of eye pain

  Eight weeks

• Adverse events

  Adverse events related to treatment

  Eight weeks

Study Arms (2)

Investigational

EXPERIMENTAL

Treatment with the ETX-4143 2.0 device

Device: ETX-4143 2.0

Control

SHAM COMPARATOR

Treatment with a sham ETX-4143 2.0 device

Device: ETX-4143 2.0

Interventions

ETX-4143 2.0 DEVICE

Treatment of the eye with the ETX-4143 2.0 device

Control; Investigational

Eligibility Criteria

• Age: 22 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented history of eye pain with no relief from currently available medications or treatments
• Willing to forgo participation in any other clinical stud for the duration of this study
• Demonstrate sufficient cognitive awareness to comply with the examination process
• Willing and able to comply with the schedule for follow-up visits
• Willing to participate in the study as evidenced by signing an informed consent document

You may not qualify if:

• Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study time period, including the follow-up period
• Any active ocular infection or active ocular inflammation at the time of the screening visit
• History of herpes keratitis, non-healing corneal epithelial defects, or neurotrophic keratopathy due to corneal herpetic disease, stem cell deficiency, diabetic keratopathy, severe lagophthalmos, or topical anesthetic abuse
• Any history of significant eye surgery with the prior 90 days
• Planned eye surgery during the entire study
• Participation in any clinical study of an investigational product within 30 days prior to enrollment
• Any history of serious, poorly controlled systemic or ophthalmic condition that could compromise the subject's ability to comply with the protocol or compromise their safety

Sponsors & Collaborators

• EyeCool Therapeutics, Inc.: lead

Study Sites (4)

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Location

Ophthamic Trials Australia

Brisbane, Queensland, 4005, Australia

Location

Innovative Eye Care

Adelaide, South Australia, 5000, Australia

Location

Sunshine Eye Surgeons

St Albans, Victoria, 3021, Australia

Location

MeSH Terms

Conditions

Eye Pain

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Study Officials

• Patrick R Casey, OD

  VP of Clinical Develpment

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 28, 2024
• Study Start: August 1, 2024
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)