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Effect of Four Different Diagnostic Eye Drops on Tear Film Thickness

NCT07230548 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-17

No results posted yet for this study

Summary

The use of topical anesthesia as well as corneal vital staining with fluorescein is an inevitable part of various ophthalmological examinations and surgical treatments. However, eye drops that don't come in single dose packages are required to contain preservatives such as chlorhexidine diacetate. An increasing number of surveys proves the partly severe side effects that preservative-containing eye drops may induce. The aim of the present study therefore is to investigate the effects of four different topical diagnostic eye drops (Novain®, Minims Oxybuprocaine Hydrochloride®, Thilorbin® and Minims®) on tear film thickness in healthy subjects. Tear film thickness will be measured at baseline and at defined time points after single instillation. The course of tear film thickness during the study day will provide information about the influence on tear film stability of the four different eye drops. Healthy subjects will receive Novain®, Minims Oxybuprocaine Hydrochloride®, Thilorbin® and Minims® eye drops on 4 different study days in a randomized order. Assessment of lipid layer thickness will be performed before and at pre-specified time points after instillation as secondary outcome. Other clinical measures such as determination of tear film break up time (TFBUT), corneal sensation, and Schirmer I test will be performed. The study will be conducted in a randomized, single masked, observer blinded four-way cross-over design. Subjects will receive all four diagnostic eye drops on 4 different study days in a randomized order.

Conditions

  • Ocular Surface Disease
  • Tear Film Characteristics

Interventions

DRUG

Oxybuprocaine MDU

the effect of instillation of 30µl of oxybuprocaine preserved as multi-dose unit (MDU) in both eyes will be investigated

DRUG

Oxybuprocaine SDU

the effect of instillation of 30µl of oxybuprocaine preserved as single-dose unit (SDU) in both eyes will be investigated

DRUG

Oxybuprocaine/fluorescein SDU

the effect of instillation of 30µl of oxybuprocaine/fluorescein preserved as single-dose unit (SDU) in both eyes will be investigated

DRUG

Fluorescein SDU

the effect of instillation of 30µl of fluorescein preserved as single-dose unit (SDU) in both eyes will be investigated

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-10
Primary Completion
2020-10-28
Completion
2020-10-28

Countries

  • Austria

Study Locations

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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 NCT07230548 on ClinicalTrials.gov