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

NCT06822608 | Not Yet Recruiting Phase 4

• 1 other identifier: CT72975
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Time to reepithelialization.

  The primary endpoint is the time to reepithelialization. Slitlamp biomicroscopy will be preformed to evaluate the integrity of the corneal media and objectively assess epithelial healing with the use of fluoroscein staining. Α record of the time needed until no staining is present will be made.

  From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.

Secondary Outcomes (3)

• Epithelial defect size in each visit

  From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.

• Subjective evaluation of pain (discomfort)

  From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.

• Subjective evaluation of vision

  From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.

Study Arms (2)

Fixed combination of dexpanthenol and hyaluronic acid eye drops

ACTIVE COMPARATOR

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

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

Placebo eye drops

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

dexpanthenol and hyaluronic acid preservative-free eye artificial tears eye drops DRUG

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. Composition: 1 ml contains Sodium Hyaluronate 0.15 %, Sodium Chloride, Sodium Citrate, Citric Acid, Water for Injections Dosage Form: Single-dose container (0.5 mL)

Fixed combination of dexpanthenol and hyaluronic acid eye drops

Placebo DRUG

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. Composition: 1 ml contains Sodium Hyaluronate 0.15 %, Sodium Chloride, Sodium Citrate, Citric Acid, Water for Injections Dosage Form: Single-dose container (0.5 mL)

Placebo eye drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

National and Kapodistrian University of Athens

Athens, Greece, 11527, Greece

Location

MeSH Terms

Interventions

dexpanthenol

Central Study Contacts

Marios P Katsimpras, MD, MSc, PhDc

CONTACT

+306970504810; katsimpras_marios@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 27, 2024
• First Posted: February 12, 2025
• Study Start: February 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: January 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Locations

GR (1)