Effect of Four Different Diagnostic Eye Drops on Tear Film Thickness

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-10

Study Completion Date

2020-10-28

Brief Summary

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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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Detailed Description

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Conditions

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Ocular Surface Disease Tear Film Characteristics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxybuprocaine MDU

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

Group Type ACTIVE_COMPARATOR

Oxybuprocaine MDU

Intervention Type DRUG

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

Oxybuprocaine SDU

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

Group Type ACTIVE_COMPARATOR

Oxybuprocaine SDU

Intervention Type DRUG

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

Fluorescein SDU

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

Group Type ACTIVE_COMPARATOR

Fluorescein SDU

Intervention Type DRUG

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

Oxybuprocaine/fluorescein SDU

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

Group Type ACTIVE_COMPARATOR

Oxybuprocaine/fluorescein SDU

Intervention Type DRUG

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

Interventions

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Oxybuprocaine MDU

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

Intervention Type DRUG

Oxybuprocaine SDU

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

Intervention Type 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

Intervention Type DRUG

Fluorescein SDU

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes