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

NCT06624384 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: IR.MUI.MED.REC.1403.129
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

PRK- ocular surface symptom - cyclosporine 0.05% - Lifitgrast (Xiidra)

Outcome Measures

Primary Outcomes (1)

• 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.

  1 week

Study Arms (3)

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

ACTIVE COMPARATOR

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

Drug: Group 1 drug

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

ACTIVE COMPARATOR

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

Drug: Group 2: Drug and placebo

Group 3: drug and placebo (Lifitgrast-Artlac)

ACTIVE COMPARATOR

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

Drug: Group 3: Drug and palcebo

Interventions

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.

Also known as: drug

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

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

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.

Group 3: drug and placebo (Lifitgrast-Artlac)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mohsen Pourazizi: lead

Study Sites (1)

Isfahan University of Medical Sciences, Feiz Hospital, Isfahan

Isfahan, Isfahan, Iran

Location

MeSH Terms

Conditions

Eye Pain; Endophthalmitis

Interventions

Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Eye Infections; Infections

Central Study Contacts

Mohsen Pourazizi, Clinical Professor

CONTACT

0098 + 09126532785; m.pourazizi@yahoo.com

mohammad sadegh khalilian, Principal Investigator

CONTACT

0098 + 09379578055; m.khalilian74@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 3, 2024
• Study Start: October 30, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-09

Locations

IR (1)