HealthyPhase 4NCT00135824
Local Tolerability and Safety of Povidone K25 Eye Drops (Artificial Tears Containing Povidone) Versus Placebo in Healthy Volunteers
A Phase 4 study testing Povidone K25 eye drops (povidone) in people with Healthy, run by Novartis at 1 site in Germany.
Trial summary
Instillation of artificial tears is standard treatment in dry eye syndrome and in patients experiencing dry eye symptoms when wearing contact lenses. Povidone K25 eye drops (povidone) is an isotonic solution containing povidone to simulate normal tears viscosity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Povidone K25 eye drops (povidone)
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2004to May 2004
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects
- Older than 18 years
- Ocular discomfort less than 20 mm on 100 mm visual analogue scale (VAS) prior to treatment
Who cannot join
- Known hypersensitivity to any of the constituents of the medications
- Known allergic disposition (e.g. hay fever)
- Wearing of contact lenses
- Any kind of current eye disease (e.g. dry eye)
- Additional exclusion criteria are defined in the protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Local Tolerability and Safety of Povidone K25 (Artificial Tears Containing Povidone) vs. Placebo in Healthy Volunteers
Instillation of artificial tears is standard treatment in dry eye syndrome and in patients experiencing dry eye symptoms when wearing contact lenses. Povidone K25 eye drops (povidone) is an isotonic solution containing povidone to simulate normal tears viscosity. Safety and local tolerability of Povidone K25 is evaluated in healthy volunteers in comparison to placebo eye drops.
- Conditions
- Healthy
- Being tested
- Povidone K25 eye drops (povidone)
- Keywords
- Artificial eye drops, tolerability, healthy volunteers, povidone, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone K25 eye drops (povidone)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular discomfort by using a visual analogue scale (VAS)
Secondary outcomes (2)
slit lamp assessment (conjunctival edema, palpebral hyperemia, lid edema)
adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startMar 2004
- Primary completionMay 2004
- Study completionMay 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- PD. Dr. G. Auffarth, Principal investigator, Universitäts-Augenklinik, Im Neuenheimer Feld 400,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00135824
- Sponsor's protocol ID
- COCF355ADE01
- Status last verified
- Nov 2011
- First submitted
- 25 Aug 2005
- Last updated
- 17 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Tolerability and Safety of Povidone K25 (Artificial Tears Containing Povidone) vs. Placebo in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00135824
- Acronym / sponsor ID
- COCF355ADE01
- Conditions
- Healthy
- Keywords
- Artificial eye drops, tolerability, healthy volunteers, povidone, healthy subjects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Mar 2004
- Primary completion
- May 2004 (actual)
- Study completion
- May 2004 (actual)
- First posted
- 26 Aug 2005 (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.
Instillation of artificial tears is standard treatment in dry eye syndrome and in patients experiencing dry eye symptoms when wearing contact lenses. Povidone K25 eye drops (povidone) is an isotonic solution containing povidone to simulate normal tears viscosity. Safety and local tolerability of Povidone K25 is evaluated in healthy volunteers in comparison to placebo eye drops.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subjects
- Older than 18 years
- Ocular discomfort less than 20 mm on 100 mm visual analogue scale (VAS) prior to treatment
Key exclusion criteria (5 listed)
- Known hypersensitivity to any of the constituents of the medications
- Known allergic disposition (e.g. hay fever)
- Wearing of contact lenses
- Any kind of current eye disease (e.g. dry eye)
- Additional exclusion criteria are defined in the protocol
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 |
|---|---|---|
| Povidone K25 eye drops (povidone) | Drug | – |
Primary outcome
ocular discomfort by using a visual analogue scale (VAS)
2 secondary outcomes
slit lamp assessment (conjunctival edema, palpebral hyperemia, lid edema)
adverse events
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 2011.
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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.
PD. Dr. G. Auffarth principal investigator
Universitäts-Augenklinik, Im Neuenheimer Feld 400,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Povidone K25 eye drops (povidone) in people with Healthy, run by Novartis at 1 site in Germany.
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 3 inclusion and 5 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 2011. 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 Germany. 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?
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?
ocular discomfort by using a visual analogue scale (VAS). 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 2011.