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

Sponsor
Campus Bio-Medico University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04812951
Collaborator
(none)
101
Enrollment
1
Location
4
Arms
12.2
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion
  • Device: cationorm eye drops
 Early Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
101 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Cyclosporine 0.1% Eye Drops as Prophylactic Treatment in Post Surgical Ocular Surface System Failure Within The Age
Actual Study Start Date :
Feb 17, 2021
Actual Primary Completion Date :
Jun 18, 2021
Anticipated Study Completion Date :
Feb 23, 2022

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Symptoms Assessment Questionnaire iN Dry Eye [4 months]

      SANDE (frequency and severity scores; 0-100)

    2. National Eye Institute grading scale [4 months]

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

    3. Rate of tears' production [4 months]

      Schirmer test (mm/5min)

    4. Tears Break Up Time [4 months]

      T-BUT (Seconds)

    Secondary Outcome Measures

    1. Biomarkers' expression in conjunctival epithelial cells [4 months]

      HLA DR (molecular expression)

    2. Biomarkers' expression in conjunctival epithelial cells [4 months]

      ICAM-1 (molecular expression)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Campus Bio Medico Rome Italy 00128

    Sponsors and Collaborators

    • Campus Bio-Medico University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Antonio Di Zazzo, Principal Investigator, Campus Bio-Medico University
    ClinicalTrials.gov Identifier:
    NCT04812951
    Other Study ID Numbers:
    • CSA2020
    First Posted:
    Mar 24, 2021
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Antonio Di Zazzo, Principal Investigator, Campus Bio-Medico University
    ocular surface disease
    Additional relevant MeSH terms:
    Inflammation
    Cyclosporine
    Ophthalmic Solutions
    Cyclosporins

    Study Results

    No Results Posted as of Jan 6, 2022