Efficacy and Safety of Topical Cyclosporine 0.05% and Lifitgrast on the Ocular Surface Symptom After Photorefractive Keratectomy in Feiz Hospital, Isfahan, 2024
NCT ID: NCT06624384
Last Updated: 2024-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
150 participants
INTERVENTIONAL
2024-10-30
2024-12-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group 1: Drug group (topical cyclosporine 0.05% and Lifitgrast)
Group 1: In this group, cyclosporine 0.05% drops are poured into one eye and Lifitgrast drops are poured into the opposite eye.
Group 1 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 (cyclosporine 0.05%-Artlac)
Group 2: In this group, cyclosporine 0.05% drops are poured into one eye and artelac drops are poured into the opposite eye.
Group 2: Drug and placebo
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 placebo (Lifitgrast-Artlac)
Group 3: In this group, Lifitgrast drops are poured into one eye and artelac drops are poured into the opposite eye.
Group 3: Drug and palcebo
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.
Interventions
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Group 1 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
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
18 Years
ALL
No
Sponsors
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Mohsen Pourazizi
OTHER
Responsible Party
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Mohsen Pourazizi
Assistant Professor of Ophthalmology
Locations
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Isfahan University of Medical Sciences, Feiz Hospital, Isfahan
Isfahan, Isfahan, Iran
Countries
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Central Contacts
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mohammad sadegh khalilian, Principal Investigator
Role: CONTACT
Facility Contacts
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Other Identifiers
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IR.MUI.MED.REC.1403.129
Identifier Type: -
Identifier Source: org_study_id
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