Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery

NCT04812951 | Completed Early Phase 1

• 1 other identifier: CSA2020
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ocular Surface Disease; Ocular Inflammation

Keywords

ocular surface disease

Outcome Measures

Primary Outcomes (4)

• Symptoms Assessment Questionnaire iN Dry Eye

  SANDE (frequency and severity scores; 0-100)

  4 months

• National Eye Institute grading scale

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

  4 months

• Rate of tears' production

  Schirmer test (mm/5min)

  4 months

• Tears Break Up Time

  T-BUT (Seconds)

  4 months

Secondary Outcomes (2)

• Biomarkers' expression in conjunctival epithelial cells

  4 months

• Biomarkers' expression in conjunctival epithelial cells

  4 months

Study Arms (4)

young control

NO INTERVENTION

25 patients \< 65 years old without any prophylactic anti-inflammatory preoperative treatment

control

NO INTERVENTION

25 patients \> 75 years old without any prophylactic anti-inflammatory preoperative treatment

Study group

EXPERIMENTAL

25 patients \> 75 years old with prophylactic anti-inflammatory preoperative treatment

Drug: CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion

Vehicle group

ACTIVE COMPARATOR

25 patients \> 75 years old with vehicle preoperative treatment

Device: cationorm eye drops

Interventions

CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion DRUG

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

Also known as: Ikervis eye drops

Study group

cationorm eye drops DEVICE

one cationorm eye drop twice a day for 30 preoperative days

Vehicle group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

University Campus Bio Medico

Rome, 00128, Italy

Location

Related Publications (13)

• 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.

  PMID: 30078540 BACKGROUND

• 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.

  PMID: 27627886 BACKGROUND

• 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.

  PMID: 28848324 BACKGROUND

• 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.

  PMID: 29504953 BACKGROUND

• 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.

  PMID: 29926365 BACKGROUND

• 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.

  PMID: 24265705 BACKGROUND

• 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.

  PMID: 29677365 BACKGROUND

• 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.

  PMID: 30515814 BACKGROUND

• 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.

  PMID: 29849499 BACKGROUND

• 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.

  PMID: 30156909 BACKGROUND

• 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.

  PMID: 29259496 BACKGROUND

• 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.

  PMID: 25325897 BACKGROUND

• 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.

  PMID: 31022299 BACKGROUND

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: March 24, 2021
• Study Start: February 17, 2021
• Primary Completion: June 18, 2021
• Study Completion: February 23, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)