Cacicol20® in Corneal Wound Healing and Nerve Regeneration After Phototherapeutic Keratectomy

Neil Lagali40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Corneal Dystrophy, Epithelial Basement Membrane Epithelial Recurrent Erosion Dystrophy Corneal Erosions

Interventions

Cacicol20DEVICE

Investigational device, regenerating agent, single-use doses, topical eye drops. Indicated for corneal wound healing.

PlaceboDEVICE

Vehicle only in identical packaging, with identical dosage and administration route.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed and dated informed consent, * Male or female aged ≥ 18 years, * Patient with recurrent erosions or epithelial dystrophies indicated for treatment by phototherapeutic keratectomy of the anterior cornea Exclusion Criteria: * In the affected eye: prior corneal surgery * In either eye: active ocular infection, glaucoma, or ocular hypertension * General history judged by the investigator to be incompatible with the study (life-threatening patient condition). * Known allergic hypersensitivity history to Poly(carboxyMethylGlucoseSulfate) or dextran. * Inability of patient to understand the study procedures and thus inability to give informed consent. * Participation in another clinical study within the last 3 months. * Already included once in this study (can only be included for one treated eye) Specific exclusion criteria for women * Known pregnancy (if uncertain pregnancy test will be performed) * Lactation * Women of childbearing potential without an effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant, vaginal ring) or women not hysterectomised, post-menopausal or surgically sterilized

Locations (2)

Linköping University Hospital

Linköping, Sweden

Sahlgrenska University Hospital

Mölndal, Sweden

Outcomes

Primary Outcomes

Percentage recovery in subbasal nerve density.

Degree of corneal subbasal nerve regeneration at one year postoperative, compared to preoperative level, as measured by clinical laser-scanning in vivo confocal microscopy.

Time frame: 12 months postoperative

Secondary Outcomes

Percentage recovery in subbasal nerve density.

Degree of corneal subbasal nerve regeneration at 6 months postoperative, compared to preoperative level, as measured by clinical laser-scanning in vivo confocal microscopy.

Time frame: 6 months postoperative

Percentage of epithelial wound closure.

A drop of sodium fluorescein liquid is applied to the cornea, and a digital photograph is taken at high magnification with a clinical slit lamp biomicroscope, using a blue illumination lamp. Area of open wound is measured from photographs and expressed as a percentage of the total treated area.

Time frame: 2 and 7 days postoperative.

Postoperative pain score on the Visual Analog Scale.

Patient self-assessment using the subjective VAS scale (100 point scale).

Time frame: Postoperative day 2, 7, month 6, 12

Corneal haze level.

Corneal haze measured microscopically by clinical in vivo confocal microscopy using a semi-quantitative grading scale.

Time frame: Postoperative month 6, 12

Number of postoperative recurrences of erosions.

As reported by the patient.

Time frame: Postoperative month 12.

Ocular surface sensitivity measured by Cochet-Bonnet esthesiometry.

Data from ClinicalTrials.gov

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