NCT05045053

Brief Summary

dry eye disease after corneal collagen cross linking affect ocular function leading to reduced vision, photophobia, glare, halos, and foreign body sensation.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2021

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

September 16, 2021

Status Verified

September 1, 2021

Enrollment Period

11 months

First QC Date

September 7, 2021

Last Update Submit

September 7, 2021

Conditions

Corneal Disease

Keywords

dry eyecross linkingxiidra

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Study Arms (2)

xiidra group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

Xiidra 5% Ophthalmic SolutionDRUG

lifitegrast 0.5% ia applied twice daily after corneal collagen cross linking

Also known as: lifitegrast
xiidra group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • corneal collagen cross linking

You may not qualify if:

  • systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INMC

Abu Dhabi, 46266, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Corneal DiseasesDry Eye Syndromes

Interventions

lifitegrastOphthalmic Solutions

Condition Hierarchy (Ancestors)

Eye DiseasesLacrimal Apparatus Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Tarek Elhamaky

    Benha university faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek R Elhamaky, M.D.

CONTACT

+971 503207889dr_thamakyy@yahoo.com

Tarek Elhamaky

CONTACT

+971 503207889dr_thamakyy@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
computer based masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assisatant professor

Study Record Dates

First Submitted

September 7, 2021

First Posted

September 16, 2021

Study Start

February 1, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

September 16, 2021

Record last verified: 2021-09

Locations

AE(1)