Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06624384
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Efficacy and Safety of Topical Cyclosporine 005 and Lifitgrast on the Ocular Surface Symptom After Photorefractive Keratectomy in Feiz Hospital Isfahan 2024
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Topical Cyclosporine 005 Restasis and Lifitgrast Xiidra on the Ocular Surface Symptom After Photorefractive Keratectomy PRK in Feiz Hospital Isfahan 2024
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to compare the administration of 2 drugs cyclosporine 005 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 005 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 005 Restasis and Lifitgrast Xiidra to a placebo Artelac artificial tears to see if cyclosporine 005 and Lifitgrast works to reduce ocular surface symptom
Participants will
Take drug cyclosporine 005 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
1- Does the use of cyclosporine 005 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 005 Restasis and Lifitgrast Xiidra to a placebo Artelac artificial tears to see if cyclosporine 005 and Lifitgrast works to reduce ocular surface symptom
Participants will
Take drug cyclosporine 005 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
Detailed 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 005 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 005 - opposite eye drop Lifitgrast The second group one eye with 005 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
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 005 - opposite eye drop Lifitgrast The second group one eye with 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None