Back to resultsEfficacy of Xiidra in Dry Eye Disease After Collagen Cross Linking
Primary Purpose
Corneal Disease
Status
Unknown status
Phase
Phase 4
Locations
United Arab Emirates
Study Type
Interventional
Intervention
Xiidra 5% Ophthalmic Solution
Sponsored by
About this trial
This is an interventional treatment trial for Corneal Disease focused on measuring dry eye, cross linking, xiidra
Eligibility Criteria
Inclusion Criteria:
- corneal collagen cross linking
Exclusion Criteria:
- systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearers
Sites / Locations
- INMCRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
xiidra group
control group
Arm Description
patients are treated with 0.5 % xiidra twice daily and artificial tears for 6 months after corneal collagen cross linking
patient are treated with artificial tears for 6 months after corneal collagen cross linking in both groups
Outcomes
Primary Outcome Measures
Change in Break up Time
fluorescein sodium stripes will be used for measurement of Break up Time in seconds at baseline and during the study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05045053
Brief Title
Efficacy of Xiidra in Dry Eye Disease After Collagen Cross Linking
Official Title
Efficacy of Xiidra in the Management Dry Eye Disease After Corneal Collagen Cross Linking
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
dry eye disease after corneal collagen cross linking affect ocular function leading to reduced vision, photophobia, glare, halos, and foreign body sensation.
Detailed Description
first group of patients were treated with 0.5 % xiidra twice daily and artificial tears for 6 months.Second group treated with artificial tears for 6 months. the treatment starts after corneal collagen cross linking in both groups ,Baseline and post-treatment full ophthalmic examination was done.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Disease
Keywords
dry eye, cross linking, xiidra
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
computer based masking
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
xiidra group
Arm Type
Experimental
Arm Description
patients are treated with 0.5 % xiidra twice daily and artificial tears for 6 months after corneal collagen cross linking
Arm Title
control group
Arm Type
No Intervention
Arm Description
patient are treated with artificial tears for 6 months after corneal collagen cross linking in both groups
Intervention Type
Drug
Intervention Name(s)
Xiidra 5% Ophthalmic Solution
Other Intervention Name(s)
lifitegrast
Intervention Description
lifitegrast 0.5% ia applied twice daily after corneal collagen cross linking
Primary Outcome Measure Information:
Title
Change in Break up Time
Description
fluorescein sodium stripes will be used for measurement of Break up Time in seconds at baseline and during the study
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
corneal collagen cross linking
Exclusion Criteria:
systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tarek R Elhamaky, M.D.
Phone
+971 503207889
Email
dr_thamakyy@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tarek Elhamaky
Phone
+971 503207889
Email
dr_thamakyy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Elhamaky
Organizational Affiliation
Benha university faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
INMC
City
Abu Dhabi
ZIP/Postal Code
46266
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TAREK R ELHAMAKY, MD
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Xiidra in Dry Eye Disease After Collagen Cross Linking
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