Efficacy of Xiidra in Dry Eye Disease After Collagen Cross Linking

NCT ID: NCT05045053

Last Updated: 2021-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Corneal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
computer based masking

Study Groups

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xiidra group

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

Group Type EXPERIMENTAL

Xiidra 5% Ophthalmic Solution

Intervention Type DRUG

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

control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Xiidra 5% Ophthalmic Solution

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

Intervention Type DRUG

Other Intervention Names

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lifitegrast

Eligibility Criteria

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Inclusion Criteria

* corneal collagen cross linking

Exclusion Criteria

* systemic or ocular diseases ,previous ocular surgery, corneal pathology and contact lens wearers
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Tarek Roshdy mohamed Mahgoub ELhamaky

assisatant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tarek Elhamaky

Role: PRINCIPAL_INVESTIGATOR

Benha university faculty of medicine

Locations

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INMC

Abu Dhabi, , United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Tarek R Elhamaky, M.D.

Role: CONTACT

+971 503207889

Tarek Elhamaky

Role: CONTACT

+971 503207889

Facility Contacts

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TAREK R ELHAMAKY, MD

Role: primary

Other Identifiers

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Hamaky17

Identifier Type: -

Identifier Source: org_study_id

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