Corneal Dystrophy, Epithelial Basement Membrane Clinical Trial
Official title:
Cacicol20® in Corneal Wound Healing and Nerve Regeneration After Phototherapeutic Keratectomy of the Anterior Cornea: A Randomized Double-Blinded Placebo-Controlled Study
The objective of this clinical study is to test the efficacy of CACICOL20® (RGTA OTR 4120) in improving wound healing and nerve regeneration in the anterior cornea, in a patient population undergoing therapeutic laser treatment for corneal dystrophy or recurrent corneal erosions.
Patients undergoing various surgical treatments of the cornea often suffer from a neural
deficit, due to nerves being severed or removed completely during surgery. This can result in
pain, impaired epithelial wound healing, reduced tear production, symptoms of dry eye, and
loss of ocular surface sensitivity/blink reflex. In addition, surgical wound healing can be
accompanied by undesirable formation of scar tissue, which can limit postoperative visual
acuity. The investigators' prior clinical experience with patients having undergone surgery
of the anterior cornea is that neural recovery is slow and incomplete, while in certain
situations scar tissue can form and limit the visual recovery.
In this context, CACICOL20®, a regenerative agent approved for use in healing corneal wounds,
presents an interesting opportunity for improving postoperative corneal nerve regeneration
and a potentially more rapid restoration of the extracellular matrix environment
postoperatively, which can lead to improved neural and visual outcomes.
The investigators will therefore evaluate the efficacy of CACICOL20® in a randomized,
double-blinded clinical study, to evaluate its ability to promote corneal nerve regeneration,
epithelial wound healing, and ocular surface recovery postoperatively.
Upon inclusion and signing of informed consent, patients undergo preoperative examination.
Upon satisfying study criteria, patients are randomized to either treatment or placebo group.
Group identity is masked to subjects and to investigators (double-blind). Subjects then
undergo therapeutic laser treatment of the cornea in a single clinic, followed by
instillation of treatment or placebo in the form of 3 eye drops total (to be given once
immediately after surgery, once 2 days after surgery, and a final time 4 days after surgery).
Postoperative eye examinations are conducted on days 2 and 7 and at month 6 and 12.
Examinations include clinical measurement of various eye and corneal wound healing
parameters.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02766907 -
Optimizing the Ocular Surface Prior to Cataract Surgery
|
N/A |