NCT03865888

Brief Summary

Evaluation of the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops in treatment of dry eye in Secondary Sjogren Syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

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

October 30, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

May 22, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

December 16, 2018

Last Update Submit

May 20, 2019

Conditions

Dry EyeSjogren Syndrome

Keywords

Sjogren SyndromeDry eyeCyclosporineTacrolimus

Outcome Measures

Primary Outcomes (3)

  • Comparison between the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops on tear film volume in dry eyes in Secondary Sjogren Syndrome patients.

    Tear film volume will be evaluated using Schirmer I test in millimetres in seconds in dry eyes before and after prescribing either cyclosporine or tacrolimus eye drops in Secondary Sjogren Syndrome patients.

    3 months follow up

  • Evaluating the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops on ocular surface damage in dry eyes in Secondary Sjogren Syndrome patients.

    Ocular surface damage will be assessed in term of calculating ocular surface staining score in dry eyes of Secondary Sjogren Syndrome patients before start and at end of treatment in cyclosporine and tacrolimus treated eyes.

    3 months follow up

  • Studying the effect of cyclosporine and tacrolimus eye drops on tear film stability in dry eyes in Secondary Sjogren Syndrome patients.

    Tear film stability will be described in form of tear film break up time in seconds in treated dry eyes of Secondary Sjogren Syndrome patients before and after adminstration of cyclosporine and tacrolimus eye drops.

    3 months follow up

Secondary Outcomes (2)

  • Evaluating the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops on meibomian glands secretion in dry eyes of Secondary Sjogren Syndrome patients.

    3 months follow up

  • Studying the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops on expressibility of meibomian glands in dry eyes of Secondary Sjogren Syndrome patients.

    3 months follow up

Study Arms (2)

Cyclosporins 0.05 % treated eyes

ACTIVE COMPARATOR

Topical Cyclosporins 0.05% eye drops twice in one eye for 3 months

Drug: Cyclosporins

Tacrolimus 0.03% treated eyes

ACTIVE COMPARATOR

Topical Tacrolimus 0.03% eye drops twice in one eye for 3 months

Drug: Tacrolimus

Interventions

CyclosporinsDRUG

Cyclosporins eye drops to be administered in dry eyes

Also known as: Restasis
Cyclosporins 0.05 % treated eyes
TacrolimusDRUG

Tacrolimus eye drops to be administered in dry eyes

Also known as: FK506
Tacrolimus 0.03% treated eyes

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed as Secondary Sjogren syndrome according to the 2002 American European consensus group (AECG) criteria, which require the presence of well defined major connective tissue disease (such as rheumatoid arthritis and systemic lupus erythematosus.
  • All patients show chronic symptoms of burning, foreign body sensation, itching in both eyes, abnormal Schirmer test \<5 mm wetting of the paper after 5 minutes, and abnormal tear breakup time (TBUT) \< 10 seconds.
  • Wash out period of 30 days before start of the immunomodulatory eye drops included in the investigator's study

You may not qualify if:

  • Any inflammation or active structural changes in the iris or anterior chamber.
  • Patients receiving or who had received systemic cyclosporine or tacrolimus.
  • Patients receiving any systemic drug that can cause dry eye as some antidepressants , antihistaminic drugs , hormonal therapy…etc
  • Glaucoma.
  • Previous ocular surgery.
  • Use of any topical medication other than artificial tears.
  • Contact lens wearers.
  • Presence of any corneal infection.
  • Any corneal diseases (ulcer, opacity, scar, bullous keratopathy, symblepharon or tumors).
  • Deforming structural lid or conjunctival abnormality.
  • Pregnancy.
  • Prior diagnosis of any of the following conditions would exclude participation in AECG study :
  • Past head and neck radiation treatment Hepatitis C infection Acquired immunodeficiency disease (AIDS) Pre-existing lymphoma Sarcoidosis Graft versus host disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pavly Moawad

Cairo, 11421, Egypt

Location

Related Publications (1)

  • Moawad P, Shamma R, Hassanein D, Ragab G, El Zawahry O. Evaluation of the effect of topical tacrolimus 0.03% versus cyclosporine 0.05% in the treatment of dry eye secondary to Sjogren syndrome. Eur J Ophthalmol. 2022 Jan;32(1):673-679. doi: 10.1177/1120672121992680. Epub 2021 Feb 2.

    PMID: 33530719DERIVED

MeSH Terms

Conditions

Dry Eye SyndromesSjogren's Syndrome

Interventions

CyclosporinsTacrolimus

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsMacrolidesLactonesOrganic Chemicals

Study Officials

  • Omar El Zawahry

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Gaafar Ragab

    Cairo University

    PRINCIPAL INVESTIGATOR

  • Rehab Shamma

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Evaluation of the effect of topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops in treatment of dry eye in Secondary Sjogren Syndrome.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer of Ophthalmic Medicine and Surgery

Study Record Dates

First Submitted

December 16, 2018

First Posted

March 7, 2019

Study Start

October 30, 2018

Primary Completion

February 1, 2019

Study Completion

April 30, 2019

Last Updated

May 22, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)