None listed
Conditions
Brief summary
The purpose of this research study is to provide safety information for a new eye pain management option for patients that have been diagnosed with moderate to severe eye pain. Ocular (Eye) surface disease is a debilitating problem causing chronic pain for many patients and is often due to more than one cause. In many of these patients, even with treatment of the underlying cause, the patient is left with persistent, symptomatic eye surface pain. Recent research has identified a link between patients with chronic ocular surface discomfort, and the sensory receptors for painful stimulus, Topical cooling has a long, well-established association with temporarily reducing peripheral peripheral nerve sensitivity. Recently, in other clinical uses of applied topical cooling, it was noted that some patients had a reduced sensitivity. The ETX-4143 device delivers a cooling treatment that is applied to the surface of the eye via a handheld medical device that contains an internal frozen (-20° Centigrade) mixture of purified water and glycerol; ETX-4143 2.0 Device does not contain an active pharmaceutical ingredient. It is applied topically to the scleral surface and the temperature is transferred via a metal plate. Depending on when you are enrolled into the study, the cooling treatment will be applied for either 30 seconds, 2 minutes, 6 minutes, or 10 minutes. Approximately 16 subjects will be enrolled at three clinical sites in Australia. There will be a total of 8 subject visits occurring over 8 weeks. Each visit should take approximately 2 hours.
Interventions
The ETX-4143 2.0 Device is a handheld medical device that contains an internal frozen (-20° Centigrade) mixture of purified water and glycerol; ETX-4143 2.0 Device does not contain an active pharmaceutical ingredient. It is applied topically to the scleral surface, following instillation of topical anesthetic drops and placement of a speculum and cornea shield. It is provided in disposable, single-use packaging. The investigational product will be administered to up to 12 (twelve) subjects meet
The ETX-4143 2.0 Device is a handheld medical device that contains an internal frozen (-20° Centigrade) mixture of purified water and glycerol; ETX-4143 2.0 Device does not contain an active pharmaceutical ingredient. It is applied topically to the scleral surface, following instillation of topical anesthetic drops and placement of a speculum and cornea shield. It is provided in disposable, single-use packaging. The investigational product will be administered to up to 12 (twelve) subjects meeting the criteria for chronic ocular pain and all protocol inclusion/exclusion criteria by a qualified physician. The duration of the ETX4143 application/exposure is dependent on the subject's chronological position during the enrollment process. There are 3 cohorts which are enrolled sequentially: Cohort A--4 subjects will have application of device for 30 seconds; (Cohort B--removed from study); Cohort C--4 subjects will have application of device for 6 minutes; Cohort D--4 subjects will have application of device for 10 minutes. The treatment time is dependent on the subject's assigned cohort. There will be a pause between enrollment of each Cohort to allow review by the Data Safety Monitor. The DSM will review one week cumulative safety date for each cohort before making recommendation for the study to progress or not to the next cohort. Subsequent subject information will be reviewed by the DSM minimally on a quarterly basis. However, the Medical Monitor will review data on a continuous basis. The study extends to a total of 8 visits over 8 weeks. Each visit is anticipated to last approximately 2 hours. The investigational device will be applied at the investigator's clinic on Day 0/Visit 2. Subsequent visits are: the screening visit/Visit 1; post-procedure day 1/Visit 3; post-procedure visits week 1-4, and 8/Visits 4-7, and 8. There is no wash out period for any previously prescribed treatment/medication. Subjects will be provided with a post procedure information sheet that has been developed by the sponsor of this study, EyeCool Therapeutics.
Sponsors
EyeCool Therapeutics, Inc
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) adult patients age 21 or older of any gender 2) At least moderate ocular surface discomfort (dryness, discomfort, grittiness, itchiness, burning, stabbing, shooting, or aching pain) that significantly improves with application of topical anesthetic in the to-be-treated eye, as per investigator assessment 3) Normal lid anatomy, blink, and closure as determined by the investigator 4) If a contact lens user, willingness to stay out of contact lenses in the treated eye for 24 hours pre- and post-procedure 5) Willingness to participate in the study as evidenced by signing of an informed consent document
Exclusion criteria
1) Pregnancy, breastfeeding, or planning to become pregnant or breastfeeding 2) Known allergy or hypersensitivity to copper, gold or aluminum. 3) Corneal Punctate Epithelial Erosions worse than 2+ in the to be treated eye as determined by Lissamine green or fluorescein staining using the Oxford Grading Scale 4) A history of corneal transplant (penetrating keratoplasty or endothelial keratoplasty), other significant corneal endothelial disease, or a history of keratoconus, corneal thinning, or other corneal ectasias 5) Any active ocular infection (bacterial, viral, or fungal), or active ocular inflammation, or any prior history of uveitis, at the time of the Screening Visit 6) A history of herpes keratitis, non-healing corneal epithelial defects, or neurotrophic keratopathy due to stem cell deficiency, diabetic keratopathy, lagophthalmos, topical anesthetic abuse, or any other cause 7) At Screening Visit, intraocular pressure (IOP) may not be less than 5 mmHg or be greater than 25 mmHg 8) Any history of significant prior conjunctival surgery (such as pterygium, trabeculectomy or scleral buckle surgery) 9) Planned eye surgery during the study period 10) Participation in any clinical study of an investigational product within 30 days prior to enrollment 11) Any change in dose in the last 30 days to a centrally acting neuromodulator (such as gabapentin, pregabalin, serotonin and norepinephrine reuptake inhibitors (SNRIs)), cannabinoid use, or to an ophthalmic anti-inflammatory drug (such topical cyclosporine (Restasis), lifitegrast (Xiidra), autologous serum tears, topical/oral steroids, or topical/oral non-steroidal anti-inflammatory drugs) 12) Any history of serious, poorly controlled systemic or ophthalmic condition or circumstances 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.
Outcome results
None listed