Efficacy and Safety of Topical Cyclosporine 0.05% and Lifitgrast on the Ocular Surface Symptom After Photorefractive Keratectomy in Feiz Hospital, Isfahan, 2024

ConditionsOcular Surface Symptom Ocular Surface Disease Eye Pain Eye Inflammation

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorMohsen Pourazizi

About this trial

The goal of this clinical trial is to compare the administration of 2 drugs, cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) before PRK, in reducing the ocular surface symptom of patients after PRK. The main questions it aims to answer are:

1- Does the use of cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) before photorefractive keratectomy surgery (PRK) reduce ocular surface symptom such as eye pain, redness, and inflammation in conjunctivitis in patients? Researchers will compare cyclosporine 0.05% (Restasis) and Lifitgrast (Xiidra) to a placebo (Artelac artificial tears) to see if cyclosporine 0.05% and Lifitgrast works to reduce ocular surface symptom.

Participants will:

Take drug cyclosporine 0.05% and Lifitgrast or a Artelac 30 minutes before surgery Visit the clinic 6 hours, one day, three days and one week after photorefractive keratectomy (PRK) for checkups and tests

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Group 1 drug
Drug
Group 1: In this group, the aim is to compare 2 drugs, cyclosporine 0.05% and Lifitgrast . In one eye, cyclosporine 0.05% eye drops are randomly poured and in the opposite eye, Lifitgrast eye drops are poured.
Group 2: Drug and placebo
Drug
Group 2: In this group, the aim is to compare 2 drugs, cyclosporine 0.05% and Artelac artificial tear as a placebo. In one eye, cyclosporine 0.05% eye drops are randomly poured, and in the opposite eye, Artelac artificial tear are poured.
Group 3: Drug and palcebo
Drug
Group 3: In this group, the aim is to compare 2 drugs, Lifitgrast and Artelac artificial tear as a placebo. In one eye, Lifitgrast eye drops are randomly poured, and in the opposite eye, Artelac artificial tear are poured.

Treatment groups

150 Participants

are divided into 3 treatment groups

Group A: Group 1: Drug group (topical cyclosporine 0.05% and Lifitgrast)Active comparator 1 intervention

Group B: Group 2: drug and placebo (cyclosporine 0.05%-Artlac)Active comparator 1 intervention

Group C: Group 3: drug and placebo (Lifitgrast-Artlac)Active comparator 1 intervention

Trial outcomes

Primary outcomes

average eye inflammatory symptoms in eyes treated with cyclosporine 0.05%, Lifitgrast and Artlac 6 hours, one day, three days and one week after photorefractive keratectomy.

The average inflammatory symptoms of the ocular surface symptoms including pain, burning and itching, redness and conjunctivitis in eyes treated with cyclosporine 0.05%, Lifitgrast and Artlac 6 hours, one day, three days and one week after photorefractive keratectomy(PRK) using a standard questionnaire including Ocular Surface Disease Index (OSDI), Visual Analogue Scale (VAS), Wang Baker FACES and Efron is measured.

Time frame

1 week

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mohsen Pourazizi

Lead sponsor

Isfahan University of Medical Sciences

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: