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From Preserved, to Preservative-free Cyclosporine 0.1% Enhanced Triple Glaucoma Therapy

NCT04673604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-07-20

No results posted yet for this study

Summary

There is a lack of evidence on the impact of switching from a combined preserved anti-glaucoma regimen to a preservative-free (PF) one, while employing sufficiently robust OSD metrics. The investigators have therefore carried out a single center, prospective, crossover investigation to compare the 6-month effect of switching well controlled open-angle glaucoma patients with at least moderate glaucoma therapy-related ocular surface disease from preserved to triple preservative-free therapy with and without cyclosporine 0.1% dosed in the evening.

Conditions

Interventions

DIAGNOSTIC_TEST

Assessment of ocular surface staining (Oxford score 0-15 scale)

Corneal and conjunctiva staining will be recorded according to the Oxford grading scheme for ocular staining (0-15 score).

DRUG

mean diurnal intraocular pressure-lowering

At the end of each 6-month period patients will undergo diurnal intraocular pressure assessment with both therapies.

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Andreas Katsanos, MD, PhD · University of Ioannina

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-06
Primary Completion
2019-12-31
Completion
2020-06-29

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04673604 on ClinicalTrials.gov