Clinical trial NCT06822608: Evaluation of Dexpanthenol and Hyaluronic Acid Eye Drops on Corneal Epithelialization After Trans Epithelial PRK
Official title: Evaluation of a Fixed Combination of Dexpanthenol and Hyaluronic Acid Preservative-free Eye Drops on Corneal Epithelialization After Trans Epithelial PRK: a Prospective, Contralateral, Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Corneal Epithelial Wound Healing
Keywords: epithelial defect
re-epithelialization
reepithelialization
dexpanthenol
trans - PRK
contrallateral study
double-blinded study
prospective study
corneal healing
corneal epithelium healing
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a contralateral, randomized, double-blind, placebo-controlled (HA) trial.

One eye of each patient, randomly determined, will be assigned to receive artificial tears containing a combination of dexpanthenol-hyaluronic acid (study group) while the fellow eye will receive Placebo / identical combination containing the same ingredients and hyaluronic acid without dexpanthenol (control group). The drops will be applied hourly postoperatively, starting one hour after the surgery. The subject will participate in 1 preoperative visit, 1 postoperatively visit and following daily visits until complete reepithelialization of both eyes or day 7 postoperatively. Researchers will compare the epithelialization between the two eyes.
Primary purpose: TREATMENT

Brief summary: The aim of this prospective, contralateral, randomized, double-blind, placebo-controlled study is the evaluation of the performance of a fixed combination of dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops, in corneal wound healing after trans epithelial photorefractive keratectomy. One eye of each patient, randomly determined, will be assigned to receive artificial tears containing a combination of dexpanthenol-hyaluronic acid (study group) while the fellow eye will receive Placebo / identical combination containing the same ingredients and hyaluronic acid without dexpanthenol (control group). The drops will be applied hourly postoperatively, starting one hour after the surgery. All subjects will be treated until the day of complete reepithelialization or a maximum of 7 days postoperatively. Researchers will compare the epithelialization between the two eyes. The primary endpoint is the time to reepithelialization.The secondary endpoints are the intra-individual differences measured in each eye in terms of epithelial defect size in each visit, subjective evaluation of pain (discomfort) and subjective evaluation of vision.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged ≥ 18
* Bilateral trans PRK for the correction of myopia using the Schwind Amaris 1050RS laser at the same treatment zone (6.5mm)
* Signed written informed consent Ability and willingness to participate in all examinations

Exclusion Criteria:

* Known hypersensitivity or intolerance to any component of the product
* Previous refractive surgery
* Myopic refractive error higher than 8.00 diopters (D)
* Anisometropia higher than 2.00 D
* Ocular or systemic disease that could affect epithelial healing

Primary outcomes:
measure: Time to reepithelialization.
timeFrame: From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.
Secondary outcomes:
measure: Epithelial defect size in each visit
timeFrame: From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.
measure: Subjective evaluation of pain (discomfort)
timeFrame: From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.
measure: Subjective evaluation of vision
timeFrame: From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.
Other outcomes:
Locations:
city: Athens
country: Greece
facility: National and Kapodistrian University of Athens
Study officials:
References: