Cacicol20® in Corneal Wound Healing and Nerve Regeneration After Phototherapeutic Keratectomy (NCT02373397) | Clinical Trial Compass
TerminatedNot Applicable
Cacicol20® in Corneal Wound Healing and Nerve Regeneration After Phototherapeutic Keratectomy
Stopped: Study terminated due to poor patient recruitment
Sweden40 participantsStarted 2015-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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