Efficacy of Xiidra in Dry Eye Disease After Collagen Cross Linking

Sponsor
Benha University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05045053
Collaborator
(none)
40
1
2
11
3.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Xiidra 5% Ophthalmic Solution
Phase 4

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
computer based masking
Primary Purpose:
Treatment
Official Title:
Efficacy of Xiidra in the Management Dry Eye Disease After Corneal Collagen Cross Linking
Actual Study Start Date :
Feb 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: xiidra group

patients are treated with 0.5 % xiidra twice daily and artificial tears for 6 months after corneal collagen cross linking

Drug: Xiidra 5% Ophthalmic Solution
lifitegrast 0.5% ia applied twice daily after corneal collagen cross linking
Other Names:
  • lifitegrast
  • No Intervention: control group

    patient are treated with artificial tears for 6 months after corneal collagen cross linking in both groups

    Outcome Measures

    Primary Outcome Measures

    1. Change in Break up Time [6 months]

      fluorescein sodium stripes will be used for measurement of Break up Time in seconds at baseline and during the study

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • corneal collagen cross linking
    Exclusion Criteria:
    • systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearers

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 INMC Abu Dhabi United Arab Emirates 46266

    Sponsors and Collaborators

    • Benha University

    Investigators

    • Principal Investigator: Tarek Elhamaky, Benha university faculty of medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tarek Roshdy mohamed Mahgoub ELhamaky, assisatant professor, Benha University
    ClinicalTrials.gov Identifier:
    NCT05045053
    Other Study ID Numbers:
    • Hamaky17
    First Posted:
    Sep 16, 2021
    Last Update Posted:
    Sep 16, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tarek Roshdy mohamed Mahgoub ELhamaky, assisatant professor, Benha University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 16, 2021