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

February 11, 2025 updated by: Katsimpras Marios, National and Kapodistrian University of Athens

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Athens, Greece, 11527
        • National and Kapodistrian University of Athens
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fixed combination of dexpanthenol and hyaluronic acid eye drops
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
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 Comparator: Placebo eye drops
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
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.
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.
From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.
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
From the day of the surgery until complete reepithelialization of both eyes or day 7 postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

September 27, 2024

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT72975

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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