Assess the Patient Feeling About the Handiness of Two Different Vials Used to Deliver Both, Unpreserved Hyaluronic Eye DropsNCT01546012
Assessment of Patient's Satisfaction Regarding the Handiness of Two Hyaluronic Acid Eye Drops Vials
A study testing HYABAK® and HYLO-COMOD® in people with Assess the Patient Feeling About the Handiness of Two Different Vials Used to Deliver Both, Unpreserved Hyaluronic Eye Drops, run by Laboratoires Thea at 1 site in Germany.
Trial summary
Assess the patient feeling about the handiness of two different vials used to deliver both, unpreserved hyaluronic eye drops. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Assess the Patient Feeling About the Handiness of Two Different Vials Used to Deliver Both, Unpreserved Hyaluronic Eye Drops
- What is being tested?
- HYABAK® and HYLO-COMOD®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman aged 18 and older
- Patient with dry eye for at least 3 months
- Having given his written informed consent
Who cannot join
- Intolerance to studied products
- Patient's inability to understand the study procedures and give informed consent.
- Patient unwilling to follow the study procedures and visits defined by the protocol.
- Pregnant or lactating women.
- Patient under guardian ship
Trial locations and contacts
1 site in 1 country.
About this study
Assess the patient feeling about the handiness of two different vials used to deliver both, unpreserved hyaluronic eye drops.
- Being tested
- HYABAK®, HYLO-COMOD®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HYABAK®Device
Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free)
HYLO-COMOD®Device
Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free)
| Study group | Role | What they receive |
|---|---|---|
| HYABAK® | Experimental | Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free) Receives: Device: HYABAK® |
| HYLO-COMOD®: | Active comparator | Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free) Receives: Device: HYLO-COMOD® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall preference of the patient
At Visit2: Week 6 +/- 1week: End of Study Visit. "Overall preference of the patient": number of answers Hyabak, Hylo-comod.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
Why it stopped: Too difficult to select patient according to the investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assess the Patient Feeling About the Handiness of Two Different Vials Used to Deliver Both, Unpreserved Hyaluronic Eye DropsStudies 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 N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Axial Biotech, Inc
- Responsible party
- Sponsor
- Investigators
- Carl Erb, Principal investigator, Augenklinik, Wittenbergplatz, Kleiststrasse 23-26, 10787 Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01546012
- Sponsor's protocol ID
- LT1550-PIV-CE-10/11
- Other IDs
- 2012-001233-14
- Status last verified
- Aug 2015
- First submitted
- 2 Mar 2012
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient's Satisfaction Regarding the Handiness of Two Hyaluronic Acid Eye Drops Vials
- ClinicalTrials.gov ID
- NCT01546012
- Acronym / sponsor ID
- LT1550-PIV-CE-10/11
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Too difficult to select patient according to the investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Collaborators
- Axial Biotech, Inc
- First posted
- 7 Mar 2012 (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.
Assess the patient feeling about the handiness of two different vials used to deliver both, unpreserved hyaluronic eye drops.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HYABAK® | Experimental | Device: HYABAK®Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free) |
| HYLO-COMOD®: | Active comparator | Device: HYLO-COMOD®Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Man or woman aged 18 and older
- Patient with dry eye for at least 3 months
- Having given his written informed consent
Key exclusion criteria (5 listed)
- Intolerance to studied products
- Patient's inability to understand the study procedures and give informed consent.
- Patient unwilling to follow the study procedures and visits defined by the protocol.
- Pregnant or lactating women.
- Patient under guardian ship
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 |
|---|---|---|
| HYABAK®Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free) | Device | HYABAK® |
| HYLO-COMOD®Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free) | Device | HYLO-COMOD®: |
Primary outcome
Overall preference of the patient
Time frame: 6 weeks
At Visit2: Week 6 +/- 1week: End of Study Visit. "Overall preference of the patient": number of answers Hyabak, Hylo-comod.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
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.
Carl Erb principal investigator
Augenklinik, Wittenbergplatz, Kleiststrasse 23-26, 10787 Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HYABAK® and HYLO-COMOD® in people with Assess the Patient Feeling About the Handiness of Two Different Vials Used to Deliver Both, Unpreserved Hyaluronic Eye Drops, run by Laboratoires Thea 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: withdrawn, as of the sponsor's last update on 2 Sep 2015. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Overall preference of the patient (time frame: 6 weeks). 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 2 Sep 2015.