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NCT Number: NCT06017362

Clinical Trial to Determine the Efficacy and Safety of Insulin Eye Drops in Dry Eye in Patients with Topical Hypotensors

The goal of this clinical trial is to evaluate the preliminary efficacy of the use of insulin eye drops in the control of dry eye disease in patients with topical hypotensors, compared to placebo (artificial tears).

The main question aims to answer whether glaucoma patients treated with topical hypotensors could benefit from the use of insulin eye drops for the treatment of dry eye.

Participants will be assigned to one of the two treatment arms and will be required to attend four follow-up visits (baseline, 1, 3, and 6 months).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location status: Recruiting

Location contact

Barbara Burgos Blasco

CONTACT

About this study

Patients will be recruited in Madrid. Patients with dry eye disease and topical glaucoma treatment will be identified through the Ophthalmology clinic. They will be directly referred to a physician who is participating in this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures.
  • Patients ≥ 18 years at the screening visit.
  • Ocular hypertension or glaucoma controlled with hypotensive treatment
  • Diagnosis of dry eye

Exclusion criteria

  • Uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months
  • Changes in topical glaucoma treatment in the last 3 months
  • Severe dry eye requiring immediate treatment
  • Previous eye surgery, except cataract surgery more than 12 months ago
  • Laser procedures less than 6 months ago
  • Other concomitant ocular pathology: scarring disease of the ocular surface, uveitis, infection in the last 90 days, trauma in the last 90 days
  • Eyelid disorders
  • Use of contact lenses
  • Other topical treatment other than dry eye and glaucoma
  • Patients with a history of allergy or hypersensitivity to the study medication or any of its excipients
  • Modifications in systemic immunosuppressive treatment in the last 6 months
  • History of alcohol or drug abuse
  • Patients who have received an experimental drug or used an experimental medical device in the 30-day period prior to the screening visit.
  • Systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or situation of the patient that does not allow examination (such as mental or psychomotor retardation).
  • Any other disease or condition that, at the discretion of the investigator, could constitute a risk to the participant or interfere with the results of the study.

Treatment and study plan

Insulin

Drug

Topical insulin 1UI/ml 4 times a day

Artificial tear

Drug

Artificial tears 4 times a day

Primary outcomes

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

    Time frame: From baseline to 6 months after treatment

    Dry eye symptoms will be evaluated using OSDI

Secondary outcomes

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

    Time frame: From baseline to 6 months after treatment

    Corneal staining will be evaluated on the slit-lamp and on slit-lamp images

  2. Change in corneal aesthesiometry from baseline to 6 months after treatment

    Time frame: From baseline to 6 months after treatment

    Aesthesiometry will be evaluated using Cochet Bonnet

  3. Change in conjunctival hyperemia from baseline to 6 months after treatment

    Time frame: From baseline to 6 months after treatment

    Conjunctival hyperemia will be evaluated using Keratograph

  4. Change in non-invasive tear film break-up time from baseline to 6 months after treatment

    Time frame: From baseline to 6 months after treatment

    Non-invasive tear film break-up time will be evaluated using Keratograph

  5. Change in light dispersion from baseline to 6 months after treatment

    Time frame: From baseline to 6 months after treatment

    Light dispersion will be evaluated using the Optical Quality Analysis System

  6. Change in cytokine levels from baseline to 6 months after treatment

    Time frame: From baseline to 6 months after treatment

    Cytokine leves will be evaluated using immunoassay

  7. Change in therapeutic compliance from baseline to 6 months after treatment

    Time frame: From baseline to 6 months after treatment

    Therapeutic compliance will be evaluated using Medication adherence rating scale (MARS). The total score ranges from 0-10 with a higher score indicating better adherence.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Burgos Blasco, MD, PhD

CONTACT

[email protected]

+34 913303000 ext. 3132

Sponsors and collaborators

Lead sponsor

Barbara Burgos Blasco

Other

Registry information

Official study title

Ensayo Clínico Para Determinar La Eficacia Y Seguridad Del Colirio De Insulina En El Tratamiento Del Ojo Seco En Pacientes Con Hipotensores Tópicos

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2023
Registry last updated
Oct 22, 2024

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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