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AzTrials

Dry EyePhase 3NCT03865888

Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome

A Phase 3 study testing Cyclosporins and Tacrolimus in people with Dry Eye and Sjogren Syndrome, run by Pavly Moawd at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Dry Eye, Sjogren Syndrome
What is being tested?
Cyclosporins and Tacrolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
30 Oct 2018to 30 Apr 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Pavly Moawad

    Cairo, 11421

Other trials in Egypt

About this study

Official title: 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

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.

Read the detailed description

Sjogren syndrome is a chronic autoimmune disorder characterized by immune cell infiltration of exocrine glands (exocrinopathy or epitheliitis) and systemic complications due to autoantibody production, immune complex deposition and lymphocytic infiltration of many organs .The loss of aqueous tear flow in Sjogren syndrome is a result of inflammatory cell infiltration of the lacrimal glands.The principal ocular manifestation of which is decreased tear production leading to chronic irritation and damage to the corneal and conjunctival epithelium. Dry eye associated with Sjogren syndrome (SS dry eye) is often more severe than non-Sjogren dry eye (non-SS dry eye). Rose bengal staining, fluorescein staining, impression cytology, and brush cytology show greater changes in SS dry eye owing to a lack of both basic tearing and reflex tearing resulting from lacrimal gland destruction, which is the hallmark of deteriorating clinical conditions.

The initial tear film ocular surface society dry eye workshop report noted the importance of ocular surface inflammation not only in the development of, but as a downstream effect and propagator of dry eye disease , and reviewed a range of therapies that function, at least in part, by anti-inflammatory mechanisms of action. Thus understanding the link between inflammation and dry eye validates the utilization of anti-inflammatory therapy in everyday practice.

Cyclosporine is understood to be an immunomodulatory drug with anti-inflammatory properties, as well as having other actions relevant to managing dry eye disease . Topical cyclosporine was approved by the FDA for the treatment of moderate-to-severe dry eye disease in 2003, based on an improvement in tear production.

Tacrolimus, a macrolide produced by Streptomyces tsukubaensis,was discovered in 1984 in Japan while searching for new immunosuppressive and cancer chemotherapeutic agents. The use of tacrolimus is of special interest in ophthalmology because it is indicated to be effective in the treatment of immune-mediated diseases Thus, the investigators performed this study to evaluate the effect of two different immunomodulatory eye drops on the ocular surface which are topical application of Tacrolimus 0.03% (FK506) eye drops versus Cyclosporine 0.05% eye drops in treatment of dry eye in Secondary Sjogren Syndrome.

Being tested
Cyclosporins, Tacrolimus
Keywords
Sjogren Syndrome, Dry eye, Cyclosporine, Tacrolimus
Medical subject headings
Dry Eye Syndromes, Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclosporinsDrug

    Also called Restasis

    Cyclosporins eye drops to be administered in dry eyes

  • TacrolimusDrug

    Also called FK506

    Tacrolimus eye drops to be administered in dry eyes

Study groups in NCT03865888
Study groupRoleWhat they receive
Cyclosporins 0.05 % treated eyesActive comparatorTopical Cyclosporins 0.05% eye drops twice in one eye for 3 months
Receives: Drug: Cyclosporins
Tacrolimus 0.03% treated eyesActive comparatorTopical Tacrolimus 0.03% eye drops twice in one eye for 3 months
Receives: Drug: Tacrolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months follow up

  2. 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.

    Measured: 3 months follow up

  3. 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.

    Measured: 3 months follow up

Secondary outcomes (2)

  1. 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.

    Comparing between effect of topical cyclosporine 0.05% and tacrolimus 0.03 % on meibomian glands secretions quality score in dry eyes of Secondary Sjogren Syndrome patients.

    Measured: 3 months follow up

  2. 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.

    Evaluating the effect of topical cyclosporine 0.05% and tacrolimus 0.03 % on meibomian glands expressibility score in dry eyes of Secondary Sjogren Syndrome patients.

    Measured: 3 months follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Mar 2019
  2. Study start30 Oct 2018
  3. Primary completion1 Feb 2019
  4. Study completion30 Apr 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03865888
Sponsor's protocol ID
N-75-2018
Status last verified
May 2019
First submitted
16 Dec 2018
Last updated
22 May 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33530719

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclosporins and Tacrolimus in people with Dry Eye and Sjogren Syndrome, run by Pavly Moawd at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 3 months follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03865888, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2019.

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