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OpenTrials
Completed

NCT Number: NCT07230548

Effect of Four Different Diagnostic Eye Drops on Tear Film Thickness

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.

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Key information

Conditions

Ocular Surface Disease Tear Film Characteristics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Men and women aged at least 18 years
  • Written informed consent prior to study-related procedures
  • Normal ophthalmic findings
  • No use of eye drops including topical lubricants in the 4 weeks before screening

Exclusion criteria

  • Participation in a clinical trial in the 3 weeks preceding the study
  • Symptoms of a clinically relevant illness in the 3 weeks before the first study day
  • Presence or history of a severe medical condition as judged by the clinical investigator
  • Intake of parasympathomimetic or anti-psychotic drugs
  • Wearing of contact lenses
  • Dry eye syndrome (Schirmer I test ≤10mm or TFBUT <10 sec.)
  • Glaucoma in the medical history
  • Treatment with corticosteroids in the 4 weeks preceding the study
  • Topical treatment with any ophthalmic drug in the 4 weeks preceding the study
  • Ocular infection or clinically significant inflammation
  • Ocular surgery in the 3 months preceding the study
  • Sjögren's syndrome
  • Stevens-Johnson syndrome
  • History of allergic conjunctivitis
  • Pregnancy, planned pregnancy or lactating
  • Known hypersensitivity to any component of the study medication

Treatment and study plan

Oxybuprocaine MDU

Drug

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

Oxybuprocaine SDU

Drug

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

Oxybuprocaine/fluorescein SDU

Drug

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

Fluorescein SDU

Drug

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

Primary outcomes

  1. Change of tear film thickness

    Time frame: Predose and at defined time points (10±5, 20±5, 40±5, 60±5, 120±10 and 240±10 minutes) after single instillation

    Change of tear film thickness as measured with optical coherence tomography predose and at defined time points (10±5, 20±5, 40±5, 60±5, 120±10 and 240±10 minutes) after single instillation

Secondary outcomes

  1. Corneal Sensation

    Time frame: Predose and at defined time points (10±5, 20±5, 40±5, 60±5, 120±10 and 240±10 minutes) after single instillation

    The measurement of corneal sensation predose and at defined time points (10±5, 20±5, 40±5, 60±5, 120±10 and 240±10 minutes) after single instillation using a Cochet-Bonnet aesthesiometer

  2. Tear film break up time

    Time frame: Change of tear film break up time predose 240±10 minutes after single instillation

    Change of tear film break up time from baseline to 240±10 minutes after single instillation

  3. Schirmer 1 test

    Time frame: Baseline to 240±10 minutes after single instillation

    Change of Schirmer 1 test as measured from baseline to 240±10 minutes after single instillation

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Effect of Single Instillation of Four Different Diagnostic Eye Drops on Tear Film Thickness in Healthy Subjects

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 17, 2025
Registry last updated
Nov 17, 2025

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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