Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06822608

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Corneal Epithelial Wound Healing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National and Kapodistrian University of Athens

Athens, Greece, 11527

Location contact

Georgios D Kymionis, Professor of Ophthalmology

CONTACT

[email protected]

+302107768000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

Primary outcomes

  1. Time to reepithelialization.

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

    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.

Secondary outcomes

  1. Epithelial defect size in each visit

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

    Epithelial defect size at each visit measured by slitlamp biomicroscopy The integrity of the corneal media is calculated from the remaining area (A) of the epithelial defects using the following equation: A=π {(α +b) /4}2 where a is the shortest dimension of the defect and b is the longest dimension.

  2. Subjective evaluation of pain (discomfort)

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

    Pain scores will be evaluated using a questionnaire on a scale of 0 to 4 as follows:

    • 0 as no discomfort or pain
    • 1 as mild discomfort
    • 2 as moderate burning pain
    • 3 as burning pain requiring oral medication (nimesulide 100 mg)
    • 4 as severe constant or sharp pain not mitigated with oral medication.

  3. Subjective evaluation of vision

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

    Uncorrected distance visual acuity measured using logMAR ETDRS charts at 4 m

Study contacts

Contact information is provided by the study sponsor or research team.

Marios P Katsimpras, MD, MSc, PhDc

CONTACT

[email protected]

+306970504810

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.