Effect of Four Different Diagnostic Eye Drops on Tear Film Thickness

NCT07230548 | Completed Phase 3 DMC

• 1 other identifier: OPHT-250618
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change of tear film thickness

  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

  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 (3)

• 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

• Tear film break up time

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

• Schirmer 1 test

  Baseline to 240±10 minutes after single instillation

Study Arms (4)

Oxybuprocaine MDU

ACTIVE COMPARATOR

Subjects will receive 30µl of oxybuprocaine preserved in multi-dose units (MDU) in both eyes after the baseline measurements on the randomized study day

Drug: Oxybuprocaine MDU

Oxybuprocaine SDU

ACTIVE COMPARATOR

Subjects will receive 30µl of oxybuprocaine preserved in single-dose units (SDU) in both eyes after the baseline measurements on the randomized study day

Drug: Oxybuprocaine SDU

Fluorescein SDU

ACTIVE COMPARATOR

Subjects will receive 30µl of fluorescein preserved in single-dose units (SDU) in both eyes after the baseline measurements on the randomized study day

Drug: Fluorescein SDU

Oxybuprocaine/fluorescein SDU

ACTIVE COMPARATOR

Subjects will receive 30µl of oxybuprocaine/fluorescein preserved in single-dose units (SDU) in both eyes after the baseline measurements on the randomized study day

Drug: Oxybuprocaine/fluorescein SDU

Interventions

Oxybuprocaine MDU DRUG

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

Oxybuprocaine MDU

Oxybuprocaine SDU DRUG

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

Oxybuprocaine SDU

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

Oxybuprocaine/fluorescein SDU

Fluorescein SDU DRUG

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

Fluorescein SDU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Department of Clinical Pharmacology, Medical University of Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

benoxinate

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof. PD Dr., PhD

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 17, 2025
• Study Start: June 10, 2020
• Primary Completion: October 28, 2020
• Study Completion: October 28, 2020
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

AU (1)