Ocular Surface DiseasePhase 3NCT07230548
Effect of Four Different Diagnostic Eye Drops on Tear Film Thickness
A Phase 3 study testing Oxybuprocaine MDU, Oxybuprocaine SDU and Oxybuprocaine/fluorescein SDU in people with Ocular Surface Disease and Tear Film Characteristics, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Surface Disease, Tear Film Characteristics
- What is being tested?
- Oxybuprocaine MDU, Oxybuprocaine SDU and Oxybuprocaine/fluorescein SDU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustria
- Study dates
- 10 Jun 2020to 28 Oct 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
About this study
Official title: Effect of Single Instillation of Four Different Diagnostic Eye Drops on Tear Film Thickness in Healthy Subjects
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
- Being tested
- Oxybuprocaine MDU, Oxybuprocaine SDU, Oxybuprocaine/fluorescein SDU, Fluorescein SDU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybuprocaine MDUDrug
the effect of instillation of 30µl of oxybuprocaine preserved as multi-dose unit (MDU) in both eyes will be investigated
Oxybuprocaine SDUDrug
the effect of instillation of 30µl of oxybuprocaine preserved as single-dose unit (SDU) in both eyes will be investigated
Oxybuprocaine/fluorescein SDUDrug
the effect of instillation of 30µl of oxybuprocaine/fluorescein preserved as single-dose unit (SDU) in both eyes will be investigated
Fluorescein SDUDrug
the effect of instillation of 30µl of fluorescein preserved as single-dose unit (SDU) in both eyes will be investigated
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Oxybuprocaine/fluorescein SDU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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 from baseline to 240±10 minutes after single instillation
Measured: Change of tear film break up time predose 240±10 minutes after single instillation
Schirmer 1 test
Change of Schirmer 1 test as measured from baseline to 240±10 minutes after single instillation
Measured: Baseline to 240±10 minutes after single instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start10 Jun 2020
- Primary completion28 Oct 2020
- Study completion28 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doreen Schmidl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230548
- Sponsor's protocol ID
- OPHT-250618
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data that support the findings of this study are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single Instillation of Four Different Diagnostic Eye Drops on Tear Film Thickness in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07230548
- Acronym / sponsor ID
- OPHT-250618
- Conditions
- Ocular Surface Disease, Tear Film Characteristics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 28 Oct 2020 (actual)
- Study completion
- 28 Oct 2020 (actual)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oxybuprocaine MDU | Active comparator | Drug: Oxybuprocaine MDUSubjects will receive 30µl of oxybuprocaine preserved in multi-dose units (MDU) in both eyes after the baseline measurements on the randomized study day |
| Oxybuprocaine SDU | Active comparator | Drug: Oxybuprocaine SDUSubjects will receive 30µl of oxybuprocaine preserved in single-dose units (SDU) in both eyes after the baseline measurements on the randomized study day |
| Fluorescein SDU | Active comparator | Drug: Fluorescein SDUSubjects will receive 30µl of fluorescein preserved in single-dose units (SDU) in both eyes after the baseline measurements on the randomized study day |
| Oxybuprocaine/fluorescein SDU | Active comparator | Drug: Oxybuprocaine/fluorescein SDUSubjects will receive 30µl of oxybuprocaine/fluorescein preserved in single-dose units (SDU) in both eyes after the baseline measurements on the randomized study day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxybuprocaine MDUthe effect of instillation of 30µl of oxybuprocaine preserved as multi-dose unit (MDU) in both eyes will be investigated | Drug | Oxybuprocaine MDU |
| Oxybuprocaine SDUthe effect of instillation of 30µl of oxybuprocaine preserved as single-dose unit (SDU) in both eyes will be investigated | Drug | Oxybuprocaine SDU |
| Oxybuprocaine/fluorescein SDUthe effect of instillation of 30µl of oxybuprocaine/fluorescein preserved as single-dose unit (SDU) in both eyes will be investigated | Drug | Oxybuprocaine/fluorescein SDU |
| Fluorescein SDUthe effect of instillation of 30µl of fluorescein preserved as single-dose unit (SDU) in both eyes will be investigated | Drug | Fluorescein SDU |
Primary outcome
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
3 secondary outcomes
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
Tear film break up time
Time frame: Change of tear film break up time predose 240±10 minutes after single instillation
Schirmer 1 test
Time frame: Baseline to 240±10 minutes after single instillation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxybuprocaine MDU, Oxybuprocaine SDU and Oxybuprocaine/fluorescein SDU in people with Ocular Surface Disease and Tear Film Characteristics, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.