Facilitation of Corneal Re-epithelialization After Photorefractive 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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Photorefractive Keratectomy and Corneal Cross-linking in Keratoconus

NCT02189447

Keratoconus

COMPLETED NA

Effect of CACICOL20 on Corneal Epithelial Healing After Cross-linking in Patients With Keratoconus

NCT02119039

Keratoconus

COMPLETED PHASE4

Treatment of Keratoconus With PALK Versus PK

NCT02625467

Keratoconus

COMPLETED PHASE1

Combined CXL//UV and PRK or LASIK in Forme Fruste Keratoconus or Eyes With Potential Risk of Ectasia

NCT01726283

Fruste Keratoconus Risk of Ectasia

COMPLETED

Blurring Strength & Aberrometric Changes Following Corneal Cross-linking (CxL) and CxL Combined With Photorefractive Keratectomy (PRK) in Keratoconus

NCT01527721

Keratoconus

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Corneal Erosion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cacicol20

One drop of Cacicol20 will be applied 4-6 hours after the surgery, in one of the randomly chosen eye, and thereafter one drop daily until the reepithelialization is completed.

Group Type EXPERIMENTAL

Cacicol20

Intervention Type DEVICE

Cacicol20 is supplied as a sterile single-dose solution of alpha 1-6 poly-carboxymethyl glucose sulfate One drop is instilled at each application to impregnate cornea.

Placebo

One drop of conservative free artificial tear (Oculac, Thea Laboratories) will be applied to one eye at the same time when Cacicol20 is instilled to the other eye.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DEVICE

Ocluac is artificial tear which contains Hydroxypropylmethyl Cellulose and Sodium Chloride, It is presented in a 0.4 mL vial. One drop is delivered at each application.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cacicol20

Cacicol20 is supplied as a sterile single-dose solution of alpha 1-6 poly-carboxymethyl glucose sulfate One drop is instilled at each application to impregnate cornea.

Intervention Type DEVICE

Placebo

Ocluac is artificial tear which contains Hydroxypropylmethyl Cellulose and Sodium Chloride, It is presented in a 0.4 mL vial. One drop is delivered at each application.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

regenerative medicine

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients undergoing bilateral PRK surgeries for treatment of refractive error
* Age over 18 years
* Refractive stability for at least 2 years

Exclusion Criteria

* Ocular pathology, including keratoconus or suspected keratoconus, glaucoma, and epithelial defects
* Previous corneal surgery
* Systemic disease that might affect corneal wound healing.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes