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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06709300




Registration number
NCT06709300
Ethics application status
Date submitted
30/10/2024
Date registered
29/11/2024

Titles & IDs
Public title
An Observational Study to Evaluate the ETX-4143 Device in Subjects With Ocular Hypertension
Scientific title
A Prospective Feasibility Study to Evaluate the Safety and Effectiveness of the ETX-4143 Device in Subjects With Ocular Hypertension
Secondary ID [1] 0 0
ETX4143-A003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ocular Hypertension 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Study Cohort - Open-label treatment group with the EyeCool ETX-4143 device in eyes with ocular hypertension that meet the inclusion/exclusion criteria
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Individual percent reduction in IOP
Timepoint [1] 0 0
From treatment to the end of twelve weeks
Primary outcome [2] 0 0
Mean reduction in intraocular pressure
Timepoint [2] 0 0
From treatment to the end of twelve weeks

Eligibility
Key inclusion criteria
1. Adult patients age =40 years of age of any gender
2. Has been diagnosed with elevated IOP (all readings should be taken within the same 4hr daytime window) with a reading of > 21mm Hg in the eye to be studied.
3. Is either not being treated for elevated IOP or is using ocular hypotensive medication to control IOP.
4. Have an open angle of the anterior chamber with evidence of trabecular meshwork visible on gonioscopy
5. Willing to forgo participation in any other clinical study for the duration of this study
6. Demonstrate sufficient cognitive awareness to comply with the examination process
7. Willing and able to comply with schedule for follow-up visits
8. Willing to participate in the study as evidenced by signing of an informed consent document
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
9. Women who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study time period, including the follow-up period
10. Known allergy or hypersensitivity to copper, aluminum, or silicone
11. Have previously undergone penetrating intraocular glaucoma surgeries (e.g., glaucoma filtering surgery, trabeculectomy, or tube bypass) in any quadrant of the study eye
12. Have undergone laser trabeculoplasty (ALT, MLT, or SLT, or cilio-ablative therapy such as cyclophotocoagulation (CPC)) within 90 days prior to starting the study
13. Any active ocular infection (bacterial, viral, or fungal), or active ocular inflammation at the time of the Screening Visit (note- potential subjects can return for rescreening at a later date after the infection or inflammation has resolved.)
14. History of corneal transplant (penetrating keratoplasy or endothelial keratoplasty), significant corneal endothelial disease, keratoconus, corneal thinning, or other corneal ectasias
15. A history of herpes keratitis, non-healing corneal epithelial defects, or neurotrophic keratopathy due to corneal herpetic disease, stem cell deficiency, diabetic keratopathy, severe lagophthalmos, topical anesthetic abuse, or any other cause
16. Any history of significant conjunctival surgery within the prior 90 days such as pterygium removal, or any presence of any subconjunctival implant (scleral buckle surgery).
17. Planned eye surgery or other ophthalmic procedures within 90 days following treatment.
18. Participation in any clinical study of an investigational product within 30 days prior to enrollment
19. Any history of serious, poorly controlled systemic or ophthalmic condition or circumstances, including those identified in the screening visit which, in the opinion of the Investigator, could compromise the subject's ability to comply with the protocol or that could compromise the subject's safety or the interpretation of the clinical trial results.
20. Neuropsychiatric disorder (e.g. psychosis, schizophrenia, mania, depression) or major psychiatric illness that has required hospitalization within the last 6 months prior to screening

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Ophthalmic Trials Australia - Brisbane
Recruitment postcode(s) [1] 0 0
4005 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
EyeCool Therapeutics, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
EyeCool Therapeutics, Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrick R Casey, OD
Address 0 0
EyeCool Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Patrick R Casey, OD
Address 0 0
Country 0 0
Phone 0 0
5104100543
Fax 0 0
Email 0 0
patrick.casey@eyecooltx.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06709300