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Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery (CSA2020)

Primary Purpose

Ocular Surface Disease, Ocular Inflammation

Status
Completed
Phase
Early Phase 1
Locations
Italy
Study Type
Interventional
Intervention
CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion
cationorm eye drops
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ocular Surface Disease focused on measuring ocular surface disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Campus Bio Medico

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

Experimental

Active Comparator

Arm Label

young control

control

Study group

Vehicle group

Arm Description

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

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

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

25 patients > 75 years old with vehicle preoperative treatment

Outcomes

Primary Outcome Measures

Symptoms Assessment Questionnaire iN Dry Eye
SANDE (frequency and severity scores; 0-100)
National Eye Institute grading scale
NEI corneal staining ( n/15 score; 0-15)
Rate of tears' production
Schirmer test (mm/5min)
Tears Break Up Time
T-BUT (Seconds)

Secondary Outcome Measures

Biomarkers' expression in conjunctival epithelial cells
HLA DR (molecular expression)
Biomarkers' expression in conjunctival epithelial cells
ICAM-1 (molecular expression)

Full Information

First Posted
March 15, 2021
Last Updated
February 13, 2023
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT04812951
Brief Title
Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery
Acronym
CSA2020
Official Title
Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in Post Surgical Ocular Surface System Failure Within The Age
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 17, 2021 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
February 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Surface Disease, Ocular Inflammation
Keywords
ocular surface disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
young control
Arm Type
No Intervention
Arm Description
25 patients < 65 years old without any prophylactic anti-inflammatory preoperative treatment
Arm Title
control
Arm Type
No Intervention
Arm Description
25 patients > 75 years old without any prophylactic anti-inflammatory preoperative treatment
Arm Title
Study group
Arm Type
Experimental
Arm Description
25 patients > 75 years old with prophylactic anti-inflammatory preoperative treatment
Arm Title
Vehicle group
Arm Type
Active Comparator
Arm Description
25 patients > 75 years old with vehicle preoperative treatment
Intervention Type
Drug
Intervention Name(s)
CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion
Other Intervention Name(s)
Ikervis eye drops
Intervention Description
one cyclosporine 0.1% eye drop twice a day for 30 preoperative days
Intervention Type
Device
Intervention Name(s)
cationorm eye drops
Intervention Description
one cationorm eye drop twice a day for 30 preoperative days
Primary Outcome Measure Information:
Title
Symptoms Assessment Questionnaire iN Dry Eye
Description
SANDE (frequency and severity scores; 0-100)
Time Frame
4 months
Title
National Eye Institute grading scale
Description
NEI corneal staining ( n/15 score; 0-15)
Time Frame
4 months
Title
Rate of tears' production
Description
Schirmer test (mm/5min)
Time Frame
4 months
Title
Tears Break Up Time
Description
T-BUT (Seconds)
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Biomarkers' expression in conjunctival epithelial cells
Description
HLA DR (molecular expression)
Time Frame
4 months
Title
Biomarkers' expression in conjunctival epithelial cells
Description
ICAM-1 (molecular expression)
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Campus Bio Medico
City
Rome
ZIP/Postal Code
00128
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Screening visit (-30 days) Cataract surgery visit 1 ( 7 days after surgery) visit 2 (15 days after surgery) visit 3 (45 days after surgery), last follow up (90 days after surgery)
Citations:
PubMed Identifier
30078540
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.
Results Reference
background
PubMed Identifier
27627886
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.
Results Reference
background
PubMed Identifier
28848324
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.
Results Reference
background
PubMed Identifier
29504953
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.
Results Reference
background
PubMed Identifier
29926365
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.
Results Reference
background
PubMed Identifier
24265705
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.
Results Reference
background
PubMed Identifier
29677365
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.
Results Reference
background
PubMed Identifier
30515814
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.
Results Reference
background
PubMed Identifier
29849499
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.
Results Reference
background
PubMed Identifier
30156909
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.
Results Reference
background
PubMed Identifier
29259496
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.
Results Reference
background
PubMed Identifier
25325897
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.
Results Reference
background
PubMed Identifier
31022299
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.
Results Reference
background

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Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery

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