Preservative-free Topical Anesthetics for Post-PRK Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-30

Study Completion Date

2023-04-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this interventional comparative study is to assess the efficacy and safety of a novel regimen of preservative-free unit-dose topical anesthetics for controlling early postoperative pain following single-step transepithelial PRK surgery.

The main research questions to answer are:

* Question 1: Are topical anesthetics effective in reducing post-PRK pain?
* Question 2: Are short-term topical anesthetics toxic to the cornea?
* Question 3: How to prevent abuse of topical anesthetics by patients at home?

Participants were planned to undergo a bilateral single-step transepithelial PRK surgery to correct their refractive errors and received a standard post-PRK treatment regimen for both eyes. Additionally, one eye was offered a preservative-free topical anesthetic as an experimental group and the other eye was offered a preservative-free artificial tear as a control group.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Topical Bromfenac for Intraoperative Miosis and Pain Reduction

NCT03831984

Cataract

UNKNOWN PHASE4

Time Serial Analysis on Preemptive Analgesia of Preoperative Topical Diclofenac and Ketorolac in Photorefractive Keratectomy(PRK)

NCT01761071

Myopes Who Have Undergone PRK.

COMPLETED PHASE3

OPI-NXYDLD-303 Safety and Efficacy of Phentolamine Ophthalmic Solution in Keratorefractive Surgery Participants With Decreased Mesopic Visual Acuity

NCT07140783

Vision Loss Night Vision Disorders

RECRUITING PHASE3

Evaluation of Efficacy and Safety of Topical 1% Medroxyprogesterone in the Corneal Epithelium Healing After PRK

NCT05973253

Photorefractive Keratectomy

COMPLETED PHASE2/PHASE3

Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections

NCT02951351

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Photorefractive keratectomy (PRK) is a well-established surface ablation procedure for correction of refractive errors which involves the removal of corneal epithelium in a large diameter usually more than 6 mm followed by stromal ablation.

Early postoperative pain within the first few days after surgery is one of the commonest complications reported after PRK. The classic postoperative treatment includes the prescription of topical antibiotics and frequent preservative-free lubricants to accelerate epithelial healing.

The current treatment regimens also includes topical steroids, topical non-steroidal anti-inflammatory drugs (NSAID) and oral NSAID to reduce inflammation and post-PRK pain.

Earlier studies suggested that topical anesthetics in diluted concentrations and fractional doses didn't delay corneal epithelial regeneration after PRK but their use didn't gain popularity because of problems with topical formulation, stability and preservation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Preservative-free topical anesthetics group

Patients in this group had the standard post-PRK treatment regimen in addition to the prescription of preservative-free topical anesthetics for pain control following single-step transepithelial PRK surgery in one eye.

Group Type EXPERIMENTAL

Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt)

Intervention Type DRUG

For each patient, one eye was treated with preservative-free Benoxinate hydrochloride 0.4%.

The prescribed regimen comprises of the instillation of one drop immediately, 2, 4, 6 and 8 hours after the end of surgery.

Every patient was given 5 UD vials only of preservative-free Benoxinate hydrochloride 0.4% at each follow up visit for the next postoperative day usage administered 5 times daily (every 3 hours while awake) for the first 3 postoperative days giving clear instructions to immediately discard the vial after single use.

Preservative-free artificial tears group

Patients in this group had the standard post-PRK treatment regimen in addition to the prescription of preservative-free artificial tears as a placebo following single-step transepithelial PRK surgery in the other eye.

Group Type PLACEBO_COMPARATOR

Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt).

Intervention Type DRUG

The other eye was treated with preservative-free Sodium hyaluronate 0.2%. The prescribed regimen comprises of the instillation of one drop immediately, 2, 4, 6 and 8 hours after the end of surgery.

Every patient was given 5 UD vials only of preservative-free Sodium hyaluronate 0.2% at each follow up visit for the next postoperative day usage administered 5 times daily (every 3 hours while awake) for the first 3 postoperative days giving clear instructions to immediately discard the vial after single use.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Preservative-free Benoxinate hydrochloride 0.4% (Benoxidia unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt)

For each patient, one eye was treated with preservative-free Benoxinate hydrochloride 0.4%.

The prescribed regimen comprises of the instillation of one drop immediately, 2, 4, 6 and 8 hours after the end of surgery.

Every patient was given 5 UD vials only of preservative-free Benoxinate hydrochloride 0.4% at each follow up visit for the next postoperative day usage administered 5 times daily (every 3 hours while awake) for the first 3 postoperative days giving clear instructions to immediately discard the vial after single use.

Intervention Type DRUG

Preservative-free Sodium hyaluronate 0.2% (Polyfresh unit-dose vials [UD], Orchidia pharmaceutical Ind., Egypt).

The other eye was treated with preservative-free Sodium hyaluronate 0.2%. The prescribed regimen comprises of the instillation of one drop immediately, 2, 4, 6 and 8 hours after the end of surgery.

Every patient was given 5 UD vials only of preservative-free Sodium hyaluronate 0.2% at each follow up visit for the next postoperative day usage administered 5 times daily (every 3 hours while awake) for the first 3 postoperative days giving clear instructions to immediately discard the vial after single use.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients who are candidate for PRK surgery with

1. Myopia up to - 6 diopters or myopic astigmatism up to - 4 diopters.
2. Corneal thinnest pachymetry of 500 µm
3. Residual stromal bed more than 350 µm after epithelial ablation.

Exclusion Criteria

Patients with

1. Corneal scars or dry eye disease,
2. Past ocular surgery,
3. History of contact lens wear,
4. Systemic diseases such as diabetes mellitus and autoimmune diseases,
5. History of oral analgesics abuse.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes