Dry Eye SyndromesPhase 4NCT02533154
Effect of Benzalkonium Chloride Containing Eye Drops on the Conjunctival Bacterial Flora of Dry Eye Patients
A Phase 4 study testing Prosicca, Prosicca sine and Bacterial culture in people with Dry Eye Syndromes, run by Medical University of Vienna at 2 sites in Austria.
Trial summary
Benzalkonium chloride (BAC) is a preservative, which is a component of more than 70% of topical ophthalmic drugs. Although BAC is a preservative with an excellent antibacterial spectrum, it has also been shown to induce toxic effects to the ocular surface. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Prosicca, Prosicca sine and Bacterial culture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesAustria
- Study dates
- 27 Jul 2015to Oct 2023
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged between 18 and 75 years.
- Signed and dated written informed consent.
- History of dry eye syndrome for at least 3 months
- Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 10 mm and ≥ 2mm
- Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt.
- Recommended use of topical lubricants, but no administration of topical lubricants 4 weeks preceding the first study day.
Who cannot join
- History or presence of ocular disease judged by the investigator as incompatible with the study.
- Any other topical ocular treatment than the study medication in the 4 weeks preceding the first study day and during the treatment period.
- Wearing of contact lenses.
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day.
- Participation in a clinical trial in the 3 weeks preceding the first study day.
- Pregnancy, lactation.
Trial locations and contacts
2 sites in 1 country.
Austria2 sites, 2 recruiting
- Recruiting
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
Gerhard Garhofer, MD, 00431 40400 ext. 29810, gerhard.garhoefer@meduniwien.ac.at
- Recruiting
Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090
Gerhard Garhoefer, MD
About this study
Benzalkonium chloride (BAC) is a preservative, which is a component of more than 70% of topical ophthalmic drugs. Although BAC is a preservative with an excellent antibacterial spectrum, it has also been shown to induce toxic effects to the ocular surface. Several studies have indicated that BAC may also have altering effects on the bacterial flora of the conjunctiva.
Since dry eye syndrome (DES) is a very common and multifactorial disease of the ocular surface and the tear fluid resulting in tear film instability, inflammation of the ocular surface, symptoms of discomfort and visual impairment, there are many different preserved as well as preservative-free ophthalmic preparations of ocular lubricants for the treatment of DES. Unpublished data from our department shows differences between artificial tears for the treatment of DES with and without BAC in bacterial culture.
Therefore, the aim of this study is to investigate the effect of artificial tear eyedrops with and without BAC on the conjunctival bacterial flora. For this 40 patients with mild or moderate dry eye syndrome with no use of artificial tears in the 4 weeks preceding the study will be recruited and treated either with the preservative-free "Prosicca sine" eyedrops or the BAC containing "Prosicca" eyedrops for one month. Conjunctival samples will be collected of one eye of each patient before and after the 1-month treatment period to compare the conjunctival bacterial flora of the two treatment groups.
- Conditions
- Dry Eye Syndromes
- Being tested
- Prosicca, Prosicca sine, Bacterial culture
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProsiccaDrug
Prosicca eyedrops Dosage: on demand Route of administration: topical
Prosicca sineDrug
Prosicca sine eyedrops Dosage: on demand Route of administration: topical
Bacterial cultureOther
bacterial cultures obtained with conjunctival swabs
| Study group | Role | What they receive |
|---|---|---|
| BAC treatment group | Experimental | 20 patients with mild or moderate dry eye syndrome receiving BAC containing Prosicca eyedrops for 1 month Receives: Drug: Prosicca; Other: Bacterial culture |
| non-BAC treatment group | Active comparator | 20 patients with mild or moderate dry eye syndrome receiving preservative-free Prosicca sine eyedrops for 1 month Receives: Drug: Prosicca sine; Other: Bacterial culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of colony forming units (CFU) in bacterial culture of conjunctival swab
Measured: 1 month
Secondary outcomes (4)
Tear Break Up Time (BUT)
Measured: 1 month
Schirmer I test
Measured: 1 month
OSDI© score
Measured: 1 month
Instillation frequency
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study start27 Jul 2015
- Primary completionSep 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533154
- Sponsor's protocol ID
- OPHT-280515
- Status last verified
- Apr 2022
- First submitted
- 24 Aug 2015
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Benzalkonium Chloride Containing Eye Drops on the Conjunctival Bacterial Flora of Dry Eye Patients
- ClinicalTrials.gov ID
- NCT02533154
- Acronym / sponsor ID
- OPHT-280515
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 27 Jul 2015 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 26 Aug 2015 (estimated)
- 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.
Benzalkonium chloride (BAC) is a preservative, which is a component of more than 70% of topical ophthalmic drugs. Although BAC is a preservative with an excellent antibacterial spectrum, it has also been shown to induce toxic effects to the ocular surface. Several studies have indicated that BAC may also have altering effects on the bacterial flora of the conjunctiva.
Since dry eye syndrome (DES) is a very common and multifactorial disease of the ocular surface and the tear fluid resulting in tear film instability, inflammation of the ocular surface, symptoms of discomfort and visual impairment, there are many different preserved as well as preservative-free ophthalmic preparations of ocular lubricants for the treatment of DES. Unpublished data from our department shows differences between artificial tears for the treatment of DES with and without BAC in bacterial culture.
Therefore, the aim of this study is to investigate the effect of artificial tear eyedrops with and without BAC on the conjunctival bacterial flora. For this 40 patients with mild or moderate dry eye syndrome with no use of artificial tears in the 4 weeks preceding the study will be recruited and treated either with the preservative-free "Prosicca sine" eyedrops or the BAC containing "Prosicca" eyedrops for one month. Conjunctival samples will be collected of one eye of each patient before and after the 1-month treatment period to compare the conjunctival bacterial flora of the two treatment groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BAC treatment group | Experimental | Drug: Prosicca, Other: Bacterial culture20 patients with mild or moderate dry eye syndrome receiving BAC containing Prosicca eyedrops for 1 month |
| non-BAC treatment group | Active comparator | Drug: Prosicca sine, Other: Bacterial culture20 patients with mild or moderate dry eye syndrome receiving preservative-free Prosicca sine eyedrops for 1 month |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged between 18 and 75 years.
- Signed and dated written informed consent.
- History of dry eye syndrome for at least 3 months
- Tear Break Up Time (BUT) ≤ 10 seconds or Schirmer I test ≤ 10 mm and ≥ 2mm
- Normal ophthalmic findings except dry eye syndrome, ametropia < 6 Dpt.
Key exclusion criteria (6 listed)
- History or presence of ocular disease judged by the investigator as incompatible with the study.
- Any other topical ocular treatment than the study medication in the 4 weeks preceding the first study day and during the treatment period.
- Wearing of contact lenses.
- Symptoms of a clinically relevant illness in the 3 weeks before the first study day.
- Participation in a clinical trial in the 3 weeks preceding the first study day.
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 |
|---|---|---|
| ProsiccaProsicca eyedrops Dosage: on demand Route of administration: topical | Drug | BAC treatment group |
| Prosicca sineProsicca sine eyedrops Dosage: on demand Route of administration: topical | Drug | non-BAC treatment group |
| Bacterial culturebacterial cultures obtained with conjunctival swabs | Other | BAC treatment group, non-BAC treatment group |
Primary outcome
Number of colony forming units (CFU) in bacterial culture of conjunctival swab
Time frame: 1 month
4 secondary outcomes
Tear Break Up Time (BUT)
Time frame: 1 month
Schirmer I test
Time frame: 1 month
OSDI© score
Time frame: 1 month
Instillation frequency
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prosicca, Prosicca sine and Bacterial culture in people with Dry Eye Syndromes, run by Medical University of Vienna at 2 sites 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gerhard Garhöfer, MD (+43 1 40400 ext. 29810, gerhard.garhoefer@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of colony forming units (CFU) in bacterial culture of conjunctival swab (time frame: 1 month). 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 7 Apr 2022.