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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06479382




Registration number
NCT06479382
Ethics application status
Date submitted
24/06/2024
Date registered
28/06/2024

Titles & IDs
Public title
Study of the ETX-4143 2.0 Device in Subjects with Eye Pain
Scientific title
A Prospective Early-Feasibility Study to Evaluate the Safety and Effectiveness of ETX-4143 2.0 Device in Subjects with Eye Pain
Secondary ID [1] 0 0
ETX4143-A002
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - ETX-4143 2.0

Experimental: Investigational - Treatment with the ETX-4143 2.0 device

Sham comparator: Control - Treatment with a sham ETX-4143 2.0 device


Treatment: Devices: ETX-4143 2.0
Treatment of the eye with the ETX-4143 2.0 device
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction of eye pain
Timepoint [1] 0 0
Eight weeks
Primary outcome [2] 0 0
Adverse events
Timepoint [2] 0 0
Eight weeks

Eligibility
Key inclusion criteria
* 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
Minimum age
22 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/11/2024
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Ophthamic 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

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
VP of Clinical Develpment
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


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/NCT06479382