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Clinical Trial To Determine The Effectiveness And Safety Of Topical Insulin In Dry Eye

Sponsor
Barbara Burgos Blasco (Other)
Overall Status
Recruiting
CT.gov ID
NCT05692739
Collaborator
(none)
120
Enrollment
1
Location
3
Arms
23.9
Anticipated Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a parallel randomized controlled trial for the treatment of dry eye disease. The main objective is to investigate the efficacy and safety of the use of insulin eye drops in the control of moderate-severe dry eye disease. Topical insulin drops will be compared to the current gold standard treatment, cyclosporin and placebo (artificial tears).

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Patients will be recruited in Madrid. Patients with dry eye disease and no topical treatment other than artificial tears will be identified through the Ophthalmology clinic. They will be directly referred to a physician who is participating in this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This will be a randomized controlled trial for the treatment of dry eye disease with three arms: topical insulin, topical cyclosporin (gold standard) and artificial tears (placebo)This will be a randomized controlled trial for the treatment of dry eye disease with three arms: topical insulin, topical cyclosporin (gold standard) and artificial tears (placebo)
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Ojo Seco
Actual Study Start Date :
Oct 5, 2022
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Insulin

Topical insulin 1UI/ml 4 times a day

Drug: Insulin
see arm description
Active Comparator: Cyclosporin

Cyclosporin 0,05% every 12 hours

Drug: Cyclosporins
see arm description
Placebo Comparator: Artificial tears

Artificial tears 4 times a day

Drug: Artificial tears
see arm description

Outcome Measures

Primary Outcome Measures

  1. Change of corneal staining from baseline to 6 months after treatment [From baseline to 6 months after treatment]

    Corneal staining will be evaluated on the slit-lamp and on slit-lamp images (masked evaluator)

Secondary Outcome Measures

  1. Changes in dry eye symptoms from baseline to 6 months after treatment time [From baseline to 6 months after treatment]

    Dry eye symptoms will be evaluated using OSDI

  2. Changes in esthesiometry from baseline to 6 months after treatment time [From baseline to 6 months after treatment]

    Esthesiometry will be evaluated using an esthesiometer

  3. Changes in tear rupture time from baseline to 6 months after treatment time [From baseline to 6 months after treatment]

    Tear rupture time will be evaluated using the Keratograph (Oculus)

Eligibility Criteria

Criteria

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

  • Patients older than 18 years

  • Dry eye disease diagnosis

  • Treatment with artificial tears or hyaluronic acid gels for at least 3 months

  • Signed informed consent by the patient

  • Staining equal to or greater than Oxford II

Exclusion Criteria:

  • Under 18 years old

  • Corneal staining under Oxford II

  • Treatment for dry eye disease other than artificial tears or hyaluronic acid gels

  • Severe dry eye disease that requires immediate treatment

  • Eye surgery in the last 6 months

  • Other concomitant corneal pathology, eyelid malpositions, nasolacrimal drainage abnormalities, blinking alterations

  • Contact lenses

  • Other treatment besides artificial tears or hyaluronic acid gels

  • Visual acuity less than 0.1

  • Allergy or intolerance to any of the components included in the study

  • Modifications in systemic immunosuppressive treatment

  • Pregnancy or lactation

  • Women of childbearing age who do not use a highly effective contraceptive method

  • History of alcohol or drug abuse

  • Participation in another clinical trial in the last 30 days

  • Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or baseline situation of the patient that does not allow the examination (such as mental or psychomotor retardation)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Clinico San Carlos Madrid Spain

Sponsors and Collaborators

  • Barbara Burgos Blasco

Investigators

  • Principal Investigator: Barbara Burgos Blasco, MD, PhD, Hospital Clinico San Carlos

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Barbara Burgos Blasco, Ophthalmologist, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT05692739
Other Study ID Numbers:
  • 22/211-EC_M
First Posted:
Jan 20, 2023
Last Update Posted:
Jan 20, 2023
Last Verified:
Jan 1, 2023
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
Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Cyclosporine
Lubricant Eye Drops
Cyclosporins

Study Results

No Results Posted as of Jan 20, 2023