Efficacy of Xiidra in Dry Eye Disease After Collagen Cros... | NCT05045053

Studies
Efficacy of Xiidra in Dry Eye Disease After Collagen Cross Linking

NCT05045053

Sponsor

Benha University

Status

Unknown status

Last Update Posted

Sep 16, 2021Actual

Enrollment

40Estimated

Phase

Phase 4

Conditions

Corneal Disease

Interventions

Xiidra 5% Ophthalmic Solution

Countries

United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2021Actual

Primary Completion Date

Jan 2022Estimated

Completion Date

Jan 2022Estimated

First Submitted Date

Sep 7, 2021

First Submission Date that Met QC Criteria

Sep 7, 2021

First Posted Date

Sep 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2021

Last Update Posted Date

Sep 16, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tarek Roshdy mohamed Mahgoub ELhamaky, assisatant professor, Benha UniversityPrincipal Investigator

Lead Sponsor

Benha UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Xiidra 5% Ophthalmic Solution	Drug	lifitegrast 0.5% ia applied twice daily after corneal collagen cross linking	xiidra group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

corneal collagen cross linking

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tarek R Elhamaky, M.D.	Contact	+971 503207889		dr_thamakyy@yahoo.com
Tarek Elhamaky	Contact	+971 503207889		dr_thamakyy@yahoo.com

Overall Officials

Name	Affiliation	Role
Tarek Elhamaky	Benha university faculty of medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
INMC	Recruiting	Abu Dhabi		46266	United Arab Emirates

Condition Browse Module

MeSH Terms

ID	Term
D003316	Corneal Diseases
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D005128	Eye Diseases
D007766	Lacrimal Apparatus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C575157	lifitegrast
D009883	Ophthalmic Solutions

Ancestor Terms

ID	Term
D019999	Pharmaceutical Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations
D045506	Therapeutic Uses

Browse Leaves

Not provided

Browse Branches

Not provided