Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery

Ocular Surface Disease Clinical Trial

— CSA2020  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04812951
• Other study ID #: CSA2020
• Status: Completed
• Phase: Early Phase 1
• Start date: February 17, 2021
• Est. completion date: February 23, 2022

Study information

• Verified date: February 2023
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: February 23, 2022
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Inflammation
• Ocular Inflammation
• Ocular Surface Disease

Intervention

Drug:
• CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion
one cyclosporine 0.1% eye drop twice a day for 30 preoperative days

Device:
• cationorm eye drops
one cationorm eye drop twice a day for 30 preoperative days

Locations

Country	Name	City	State
Italy	University Campus Bio Medico	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms Assessment Questionnaire iN Dry Eye	SANDE (frequency and severity scores; 0-100)	4 months
Primary	National Eye Institute grading scale	NEI corneal staining ( n/15 score; 0-15)	4 months
Primary	Rate of tears' production	Schirmer test (mm/5min)	4 months
Primary	Tears Break Up Time	T-BUT (Seconds)	4 months
Secondary	Biomarkers' expression in conjunctival epithelial cells	HLA DR (molecular expression)	4 months
Secondary	Biomarkers' expression in conjunctival epithelial cells	ICAM-1 (molecular expression)	4 months