Clinical trial NCT04812951: Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery
Official title: Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in Post Surgical Ocular Surface System Failure Within The Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Ocular Surface Disease
Ocular Inflammation
Keywords: ocular surface disease
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Symptoms Assessment Questionnaire iN Dry Eye
timeFrame: 4 months
measure: National Eye Institute grading scale
timeFrame: 4 months
measure: Rate of tears' production
timeFrame: 4 months
measure: Tears Break Up Time
timeFrame: 4 months
Secondary outcomes:
measure: Biomarkers' expression in conjunctival epithelial cells
timeFrame: 4 months
measure: Biomarkers' expression in conjunctival epithelial cells
timeFrame: 4 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University Campus Bio Medico
Study officials:
References:
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.
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citation: 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.
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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.
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