Topical Cyclosporine A for the Treatment of Dry Eye: A Randomized Clinical Study

NCT04714099 | Completed Phase 3

• 1 other identifier: 123456
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Since the initial description, the therapeutic efficacy of CsA for human KCS has been well documented, with evidence ranging from several small single center randomized double-masked clinical trials to several large multicenter randomized, double-masked clinical trials.(10-12) Therefore, the aim of the work is to evaluate the effect of using topical CsA in treatment of moderate to severe dry eye.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (1)

• Tear Break up Time

  Measuring the time lapse between last blink after instillation of fluorescein and appearance of the first dry spot on the corneal surface

  3 months

Secondary Outcomes (4)

• Schirmer test

  3 months

• Intra ocular pressure

  3 months

• Fluorescein staining (Oxford Grading Scale)

  3 months

• OSDI Scores

  3 months

Study Arms (2)

Topical CsA

EXPERIMENTAL

Group A received topical CsA 0.05% for 3 months

Drug: Topical Cyclosporine A

Control

PLACEBO COMPARATOR

Placebo group

Drug: Placebo

Interventions

Topical Cyclosporine A DRUG

In our study we used 0.05% CsA prepared in castor oil by transferring (20ml ) of sterile castor oil in a sterile glass vial under laminar flow, removing a volume (400ul)of oil with micropipette (sterile tips), and replacing this volume with an equal volume of alcoholic CsA solution \[200mg cyclosporine in 8 ml ethanol (96%)\] under laminar flow.

Topical CsA

Placebo DRUG

Placebo

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• We included all patients with moderate to severe dry eye disease (grade 3 or grade 4) with the following criteria: The tear film break up time ≤5 seconds for grade 3 and immediate for grade 4, schirmer test with anesthetic is ≤5 millimeters for grade 3 and ≤2 millimeters for grade 4, corneal or conjunctival staining pattern with fluorescein is abnormal and consistent with an abnormal tear film. Oxford grade II or more, meibomian gland dysfunction is documented (inspissation of the meibomian gland orifices, pitting and neovascularization of the eyelid margins) and one or more moderate (≥2+) dry eye related symptoms; including itching, burning, blurred vision, foreign body sensation, photophobia, veiling, and soreness or pain

Sponsors & Collaborators

• Alexandria University: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Ehab Mossallam, PhD

  Alexandria Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is prospective randomized comparative clinical study that included 80 eyes of 40 patients with moderate to severe DED. Patients were divided into two groups; group A received topical CsA 0.05% for 3 months, and group B were controls.

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: January 19, 2021
• Study Start: January 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 30, 2015
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share