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AzTrials

Ocular Surface DiseaseEarly Phase 1CSA2020NCT04812951

Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery

A Early Phase 1 study testing CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion and cationorm eye drops in people with Ocular Surface Disease and Ocular Inflammation, run by Campus Bio-Medico University at 1 site in Italy.

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

Use of Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in cataract Surgery Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ocular Surface Disease, Ocular Inflammation
What is being tested?
CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion and cationorm eye drops
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteItaly
Study dates
17 Feb 2021to 23 Feb 2022
Phase
Early Phase 1
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >18 years old
  • Postmenopausal women for whom cataract surgery has been scheduled
  • Stage N2-3; C1-2 according (Lens Opacities classification System) LOCS
  • Willing to sign informed consent and fully participate to all length of the study
  • Patients without any previous medical history of ocular and/or systemic inflammatory, autoimmune or auto inflammatory disease
  • Patient with no history of ocular surgery
  • Patients without any previous or concomitant ocular diseases

Who cannot join

  • Patients under topical or systemic anti- inflammatory drugs Patients with a concomitant diagnosis of glaucoma, or on therapy with antiglaucoma drugs
  • Patients on systemic or local therapy with drugs that alter the secretion of the tear film (beta blockers, antidepressants and psychotropics)
  • Patients with a history of allergic, congenital, autoimmune systemic diseases
  • Patients who have undergone previous eye surgery
  • Ocular or peri-ocular malignancies or premalignant conditions
  • Active or suspected ocular or peri-ocular infection.
Show all 9Show fewer
  • Complicated Cataract Surgery
  • Patients with a positive pregnancy testAllergy or reaction history to study drug
  • Patients who participated in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives of the study drug

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • University Campus Bio Medico

    Rome, 00128

Other trials in Italy

About this study

Official title: Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in Post Surgical Ocular Surface System Failure Within The Age

Use of Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in cataract Surgery

Read the detailed description

To asses ocular discomfort symptoms and signs and inflammatory biomarkers after preoperative topical cyclosporine 0.1% eye drops therapy in high risk elder population after a specific insult such as cataract surgery.

Being tested
CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion, cationorm eye drops
Keywords
ocular surface disease

What participants receive

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

  • CycloSPORINE Ophthalmic 0.1% Ophthalmic EmulsionDrug

    Also called Ikervis eye drops

    one cyclosporine 0.1% eye drop twice a day for 30 preoperative days

  • cationorm eye dropsDevice

    one cationorm eye drop twice a day for 30 preoperative days

Study groups in NCT04812951
Study groupRoleWhat they receive
young controlNo intervention25 patients < 65 years old without any prophylactic anti-inflammatory preoperative treatment
controlNo intervention25 patients > 75 years old without any prophylactic anti-inflammatory preoperative treatment
Study groupExperimental25 patients > 75 years old with prophylactic anti-inflammatory preoperative treatment
Receives: Drug: CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion
Vehicle groupActive comparator25 patients > 75 years old with vehicle preoperative treatment
Receives: Device: cationorm eye drops

What is being measured

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

  1. Symptoms Assessment Questionnaire iN Dry Eye

    SANDE (frequency and severity scores; 0-100)

    Measured: 4 months

  2. National Eye Institute grading scale

    NEI corneal staining ( n/15 score; 0-15)

    Measured: 4 months

  3. Rate of tears' production

    Schirmer test (mm/5min)

    Measured: 4 months

  4. Tears Break Up Time

    T-BUT (Seconds)

    Measured: 4 months

Secondary outcomes (2)

  1. Biomarkers' expression in conjunctival epithelial cells

    HLA DR (molecular expression)

    Measured: 4 months

  2. Biomarkers' expression in conjunctival epithelial cells

    ICAM-1 (molecular expression)

    Measured: 4 months

Timeline

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

  1. First posted24 Mar 2021
  2. Study start17 Feb 2021
  3. Primary completion18 Jun 2021
  4. Study completion23 Feb 2022

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
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04812951
Sponsor's protocol ID
CSA2020
Acronym
CSA2020
Status last verified
Feb 2023
First submitted
15 Mar 2021
Last updated
14 Feb 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 1. Screening visit (-30 days) 2. Cataract surgery 3. visit 1 ( 7 days after surgery) 4. visit 2 (15 days after surgery) 5. visit 3 (45 days after surgery), 6. last follow up (90 days after surgery)

Publications

  • Gupta PK, Drinkwater OJ, VanDusen KW, Brissette AR, Starr CE. Prevalence of ocular surface dysfunction in patients presenting for cataract surgery evaluation. J Cataract Refract Surg. 2018 Sep;44(9):1090-1096. doi: 10.1016/j.jcrs.2018.06.026. Epub 2018 Aug 2.

    PubMed 30078540

  • Kim JS, Lee H, Choi S, Kim EK, Seo KY, Kim TI. Assessment of the Tear Film Lipid Layer Thickness after Cataract Surgery. Semin Ophthalmol. 2018;33(2):231-236. doi: 10.1080/08820538.2016.1208764. Epub 2016 Sep 14.

    PubMed 27627886

  • Trattler WB, Majmudar PA, Donnenfeld ED, McDonald MB, Stonecipher KG, Goldberg DF. The Prospective Health Assessment of Cataract Patients' Ocular Surface (PHACO) study: the effect of dry eye. Clin Ophthalmol. 2017 Aug 7;11:1423-1430. doi: 10.2147/OPTH.S120159. eCollection 2017.

    PubMed 28848324

  • Iglesias E, Sajnani R, Levitt RC, Sarantopoulos CD, Galor A. Epidemiology of Persistent Dry Eye-Like Symptoms After Cataract Surgery. Cornea. 2018 Jul;37(7):893-898. doi: 10.1097/ICO.0000000000001491.

    PubMed 29504953

  • Kohli P, Arya SK, Raj A, Handa U. Changes in ocular surface status after phacoemulsification in patients with senile cataract. Int Ophthalmol. 2019 Jun;39(6):1345-1353. doi: 10.1007/s10792-018-0953-8. Epub 2018 Jun 20.

    PubMed 29926365

  • Kasetsuwan N, Satitpitakul V, Changul T, Jariyakosol S. Incidence and pattern of dry eye after cataract surgery. PLoS One. 2013 Nov 12;8(11):e78657. doi: 10.1371/journal.pone.0078657. eCollection 2013.

    PubMed 24265705

  • Micera A, Di Zazzo A, Esposito G, Longo R, Foulsham W, Sacco R, Sgrulletta R, Bonini S. Age-Related Changes to Human Tear Composition. Invest Ophthalmol Vis Sci. 2018 Apr 1;59(5):2024-2031. doi: 10.1167/iovs.17-23358.

    PubMed 29677365

  • Di Zazzo A, Micera A, De Piano M, Cortes M, Bonini S. Tears and ocular surface disorders: Usefulness of biomarkers. J Cell Physiol. 2019 Jul;234(7):9982-9993. doi: 10.1002/jcp.27895. Epub 2018 Dec 4.

    PubMed 30515814

  • Olivieri F, Prattichizzo F, Grillari J, Balistreri CR. Cellular Senescence and Inflammaging in Age-Related Diseases. Mediators Inflamm. 2018 Apr 17;2018:9076485. doi: 10.1155/2018/9076485. eCollection 2018. No abstract available.

    PubMed 29849499

  • Baker JR, Vuppusetty C, Colley T, Hassibi S, Fenwick PS, Donnelly LE, Ito K, Barnes PJ. MicroRNA-570 is a novel regulator of cellular senescence and inflammaging. FASEB J. 2019 Feb;33(2):1605-1616. doi: 10.1096/fj.201800965R. Epub 2018 Aug 29.

    PubMed 30156909

  • Ventura MT, Casciaro M, Gangemi S, Buquicchio R. Immunosenescence in aging: between immune cells depletion and cytokines up-regulation. Clin Mol Allergy. 2017 Dec 14;15:21. doi: 10.1186/s12948-017-0077-0. eCollection 2017.

    PubMed 29259496

  • Torricelli AA, Santhiago MR, Wilson SE. Topical cyclosporine a treatment in corneal refractive surgery and patients with dry eye. J Refract Surg. 2014 Aug;30(8):558-64. doi: 10.3928/1081597X-20140711-09.

    PubMed 25325897

  • Di Zazzo A, Micera A, Coassin M, Varacalli G, Foulsham W, De Piano M, Bonini S. InflammAging at Ocular Surface: Clinical and Biomolecular Analyses in Healthy Volunteers. Invest Ophthalmol Vis Sci. 2019 Apr 1;60(5):1769-1775. doi: 10.1167/iovs.18-25822.

    PubMed 31022299

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion and cationorm eye drops in people with Ocular Surface Disease and Ocular Inflammation, run by Campus Bio-Medico University at 1 site in Italy.

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 7 inclusion and 9 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 14 Feb 2023. 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 Italy. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Symptoms Assessment Questionnaire iN Dry Eye (time frame: 4 months). The study lists 4 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 NCT04812951, which also lists 13 linked publications.

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 14 Feb 2023.

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