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

February 13, 2023 updated by: Antonio Di Zazzo, Campus Bio-Medico University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00128
        • University Campus Bio Medico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: young control
25 patients < 65 years old without any prophylactic anti-inflammatory preoperative treatment
NO_INTERVENTION: control
25 patients > 75 years old without any prophylactic anti-inflammatory preoperative treatment
EXPERIMENTAL: Study group
25 patients > 75 years old with prophylactic anti-inflammatory preoperative treatment
Drug: CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion
one cyclosporine 0.1% eye drop twice a day for 30 preoperative days
Other Names:
  • Ikervis eye drops
ACTIVE_COMPARATOR: Vehicle group
25 patients > 75 years old with vehicle preoperative treatment
Device: cationorm eye drops
one cationorm eye drop twice a day for 30 preoperative days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms Assessment Questionnaire iN Dry Eye
Time Frame: 4 months
SANDE (frequency and severity scores; 0-100)
4 months
National Eye Institute grading scale
Time Frame: 4 months
NEI corneal staining ( n/15 score; 0-15)
4 months
Rate of tears' production
Time Frame: 4 months
Schirmer test (mm/5min)
4 months
Tears Break Up Time
Time Frame: 4 months
T-BUT (Seconds)
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers' expression in conjunctival epithelial cells
Time Frame: 4 months
HLA DR (molecular expression)
4 months
Biomarkers' expression in conjunctival epithelial cells
Time Frame: 4 months
ICAM-1 (molecular expression)
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 17, 2021

Primary Completion (ACTUAL)

June 18, 2021

Study Completion (ACTUAL)

February 23, 2022

Study Registration Dates

First Submitted

March 15, 2021

First Submitted That Met QC Criteria

March 19, 2021

First Posted (ACTUAL)

March 24, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSA2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

  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)

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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