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OpenTrials
Completed

NCT Number: NCT04812951

Cyclosporine 0.1% Eye Drops as Prophylactic Treatment In Cataract Surgery

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University Campus Bio Medico

Rome, 00128, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion

Drug

one cyclosporine 0.1% eye drop twice a day for 30 preoperative days

Other names: Ikervis eye drops

cationorm eye drops

Device

one cationorm eye drop twice a day for 30 preoperative days

Primary outcomes

  1. Symptoms Assessment Questionnaire iN Dry Eye

    Time frame: 4 months

    SANDE (frequency and severity scores; 0-100)

  2. National Eye Institute grading scale

    Time frame: 4 months

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

  3. Rate of tears' production

    Time frame: 4 months

    Schirmer test (mm/5min)

  4. Tears Break Up Time

    Time frame: 4 months

    T-BUT (Seconds)

Secondary outcomes

  1. Biomarkers' expression in conjunctival epithelial cells

    Time frame: 4 months

    HLA DR (molecular expression)

  2. Biomarkers' expression in conjunctival epithelial cells

    Time frame: 4 months

    ICAM-1 (molecular expression)

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

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

Acronym: CSA2020

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Mar 24, 2021
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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