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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2017-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cacicol20

Instillation of Cacicol20 eye drops after laser corneal surgery. 3 eye drops total, to be given once immediately after surgery, once 2 days after surgery, and a final time 4 days after surgery.

Group Type EXPERIMENTAL

Cacicol20

Intervention Type DEVICE

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

Placebo

Instillation of placebo eye drops (vehicle missing the active ingredient) after laser corneal surgery. 3 eye drops total, to be given once immediately after surgery, once 2 days after surgery, and a final time 4 days after surgery.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

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

Interventions

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Cacicol20

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

Intervention Type DEVICE

Placebo

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

Intervention Type DEVICE

Other Intervention Names

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RGTA Cacicol RGTA OTR 4120

Eligibility Criteria

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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)

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No