Corneal Erosion Clinical Trial
Official title:
Treatment of Postoperative Discomfort/Pain and Facilitation of Corneal Reepithelialization After Photorefractive Keratectomy
Photorefractive keratectomy (PRK) or surface ablation is one of the most commonly used
surgical procedures to correct refractive errors, which was proved to be safe and effective.
In PRK, the corneal epithelium is removed by various techniques such as diluted alcohol,
manual debridement, brush, or excimer laser, before the refractive excimer laser ablation of
the corneal stroma. Compared to laser in situ keratomileusis (LASIK), the two main drawbacks
for PRK are slower visual recovery and discomfort in the immediate postoperative period, due
to the epithelial removal.
Corneal healing is a complex process involving cellular interaction and reaction with various
molecules (proteases, growth factors, and epithelial and stromal cytokines). Enhanced corneal
re-epithelialization may reduce the risk for corneal infection and stromal scarring or
melting. Over the past few years, a new type of matrix therapy by ReGeneraTing Agent (RGTA)
has provided encouraging results, accelerating the healing of chronic skin ulcers in diabetes
or vascular origin. RGTAs mimic the action of heparin sulfate molecules, breaking the
negative repair-destruction cycle occurring in chronic lesions and inhibit proteolytic
enzymes in vitro. In the domain of ophthalmology, RGTA has been reported to show encouraging
results in the treatment of corneal ulcer and dystrophies of various etiologies.
The Cacicol20 is an RGTA that binds to matrix proteins to protect them from proteolysis; the
extracellular matrix microenvironment protection improves the production of signals and
growth factors needed for tissue healing. It is supplied as a sterile single-dose solution of
alpha 1-6 poly-carboxymethyl glucose sulfate described and synthesized as in US Patent Number
6689741, with dextran T40 and 0.9% sodium chloride as excipients. It contains no component of
animal or biological origin, and penetrates into the cornea without crossing Descemet´s
membrane (no intraocular penetration). The Cacicol20 has been reported to be effective in
treatment of neurotrophic ulcers and persistent epithelial defects which were unresponsive to
the common treatment approaches. Therefore, we expect that the Cacicol20 may facilitate the
corneal re-epithelialization after PRK.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05956535 -
Air Optix® Night and Day® Aqua Therapeutic Wear
|
||
| Not yet recruiting |
NCT06381986 -
Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients
|
Phase 2 | |
| Completed |
NCT05891106 -
AONDA Therapeutic Indication Study I
|