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

Mohsen Pourazizi

Status and phase: Not yet enrolling; Phase 1

Conditions: Eye Pain; Ocular Surface Disease; Eye Inflammation; Ocular Surface Symptom

Treatments: Drug: Group 3: Drug and palcebo; Drug: Group 2: Drug and placebo; Drug: Group 1 drug

Study type: Interventional

Funder types: Other

Identifiers

NCT06624384

IR.MUI.MED.REC.1403.129

Details and patient eligibility

About

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

Full description

Considering the increasing importance of reducing eye symptoms of patients after PRK surgery and the impact of this issue on the quality of life of patients, as well as the lack of sufficient studies on the effect of different drugs in this field and comparing their effects, which ultimately lead to the decision and clinical application of this Regarding the category of drugs, the present study aims to compare the administration of 2 drugs, cyclosporine 0.05% and Lifitgrast before PRK, in reducing the eye symptoms of patients after PRK.

In this study, 15 minutes before the start of photorefractive keratectomy surgery, we divide the patients into 3 random groups and according to the following plan, we put the drops into the eyes of the patients.

The first group: one eye drop cyclosporine 0.05% - opposite eye drop Lifitgrast The second group: one eye with 0.05% cyclosporine drops - the opposite eye with Artlac artificial tear drops The third group: one eye with Liffitgrast drops - the opposite eye with Artlac artificial tear drops Patients will be evaluated and examined according to variables 6 hours, one day, three days and one week after the operation. To check the symptoms of patients from standard questionnaires including Ocular surface disease index (OSDI), visual analogue scale (VAS) Wong-Baker FACES, Efron is used.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Age above 18 years Myopia and myopic astigmatism The stability of the patients refraction over the past year Not using contact lenses at least 3 weeks before the operation Absence of history of KCN and any type of corneal ectasia in the patient himself or his first degree family No history of previous eye surgery and eye trauma Absence of active eye diseases, corneal dystrophy, retinal diseases, glaucoma, dry eyes of any degree.

Absence of systemic diseases that can potentially disrupt wound healing, including diabetes, vascular collagen diseases, and pregnancy.

Not taking inhaled or systemic steroids actively or within 3 months before the procedure Absence of anisometropia Not using any systemic and topical analgesia during the last week

Exclusion criteria

The patients lack of consent to continue the study Failure to visit the patient for follow-up The occurrence of any complications during the patients surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 3 patient groups

Group 1: Drug group (topical cyclosporine 0.05% and Lifitgrast)

Active Comparator group

Description:

Group 1: In this group, cyclosporine 0.05% drops are poured into one eye and Lifitgrast drops are poured into the opposite eye.

Treatment:

Drug: Group 1 drug

Group 2: drug and placebo (cyclosporine 0.05%-Artlac)

Active Comparator group

Description:

Group 2: In this group, cyclosporine 0.05% drops are poured into one eye and artelac drops are poured into the opposite eye.

Treatment:

Drug: Group 2: Drug and placebo

Group 3: drug and placebo (Lifitgrast-Artlac)

Active Comparator group

Description:

Group 3: In this group, Lifitgrast drops are poured into one eye and artelac drops are poured into the opposite eye.

Treatment:

Drug: Group 3: Drug and palcebo