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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital Clinico San Carlos
RECRUITING
Madrid
Contact Information
Primary
Barbara Burgos Blasco, MD, PhD
bburgos171@hotmail.com
+34 913303000
Time Frame
Start Date: 2023-02-08
Estimated Completion Date: 2026-02-08
Participants
Target number of participants: 100
Treatments
Experimental: Insulin
Topical insulin 1UI/ml 4 times a day
Placebo_comparator: Placebo (artificial tears)
Artificial tears 4 times a day
Related Therapeutic Areas
Sponsors
Leads: Barbara Burgos Blasco

This content was sourced from clinicaltrials.gov