Health TrialsbyHealthPanel

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

ConditionsDry EyeGlaucoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBarbara Burgos Blasco

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Insulin

    Drug

    Topical insulin 1UI/ml 4 times a day

  • Artificial tear

    Drug

    Artificial tears 4 times a day

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: InsulinExperimental treatment 1 intervention
Group B: Placebo (artificial tears)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Dry eye symptoms will be evaluated using OSDI

Time frame
From baseline to 6 months after treatment

Secondary outcomes

1

Change of corneal staining from baseline to 6 months after treatment

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

Time frame
From baseline to 6 months after treatment
2

Change in corneal aesthesiometry from baseline to 6 months after treatment

Aesthesiometry will be evaluated using Cochet Bonnet

Time frame
From baseline to 6 months after treatment
3

Change in conjunctival hyperemia from baseline to 6 months after treatment

Conjunctival hyperemia will be evaluated using Keratograph

Time frame
From baseline to 6 months after treatment
4

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

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

Time frame
From baseline to 6 months after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Barbara Burgos Blasco

Lead sponsor

Hospital San Carlos, Madrid

Sponsor institution

Source ClinicalTrials.gov
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