A first in human safety study of ETX-4143 (a topical cooling device for the eye) in subjects with chronic eye pai

Not Applicable

Recruiting

• Conditions: chronic ocular pain; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12622001113741
• Lead Sponsor: EyeCool Therapeutics, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-12
• Last Update Posted: 9 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified