Evaluation of Dexpanthenol and Hyaluronic Acid Eye Drops on Corneal Epithelialization After Trans Epithelial PRK

National and Kapodistrian University of Athens

Status and phase: Not yet enrolling; Phase 4

Conditions: Corneal Epithelial Wound Healing

Treatments: Drug: Placebo; Drug: dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT06822608

CT72975

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups, including a placebo group

Fixed combination of dexpanthenol and hyaluronic acid eye drops

Active Comparator group

Description:

Subjects will receive 1 drop of a fixed combination of dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops (DexHA) hourly during the day, but at least 12 times a day, until complete reepithelialization

Treatment:

Drug: dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops

Placebo eye drops

Placebo Comparator group

Description:

Subjects will receive 1 drop of a hyaluronic acid preservative-free eye artificial tears eye drops (HA) as PLACEBO hourly during the day, but at least 12 times a day, until complete reepithelialization

Treatment:

Drug: Placebo