Cacicol20® in Corneal Wound Healing and Nerve Regeneration After Phototherapeutic Keratectomy (CACICOL-PTK)
Corneal Dystrophy, Epithelial Basement Membrane, Epithelial Recurrent Erosion Dystrophy, Corneal Erosions
About this trial
This is an interventional supportive care trial for Corneal Dystrophy, Epithelial Basement Membrane focused on measuring Wound healing, nerve regeneration, re-epithelialization, corneal epithelium, laser corneal surgery
Eligibility Criteria
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
Sites / Locations
- Linköping University Hospital
- Sahlgrenska University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Cacicol20
Placebo
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.
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.