Dry Eye SyndromeNCT01957670
Pilot Study to Clinical Evaluate Device Prototypes in Dry Eye Patients
A study testing Lacrima medical Prototypes in people with Dry Eye Syndrome, run by Lacrima Medical LTD at 1 site in Israel.
Trial summary
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device to treat dry eye patients Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Lacrima medical Prototypes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2014to Apr 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Male or female, 18 years of age and over at screening
- Diagnosis of mild to moderate Dry Eye, as defined by:
- Positive corneal fluorescein staining , defined as a corneal punctate fluorescein staining score of ≥3 in either eye by the National Eye Institute evaluation scale summed over 5 areas, each with a 0-3 scoring scale; AND
- Schirmer Test score (with anesthesia, 5 minutes < 5 mm either eye) ; AND
- OSDI score of ≥12 and OSDI score of <33
Main Exclusion Criteria:
- Persistent intraocular inflammation or infection including conjunctivitis at the time of the study or 2 weeks prior to study start.
- Any concomitant active or history of eye disease including, but not limited to lid abnormalities, nasolacrimal obstruction, active ulcer, glaucoma or ocular herpes simplex virus infection
- Patients currently using topical steroidal or anti-inflammatory eye drops for 1 month prior to screening
- Receipt of any type of topical artificial eye drops within 3 days prior to screening
- Receipt of topical cyclosporine eye drops within 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot, Open-label, Single-Arm Study Designed to Clinically Evaluate Various Lacrima Medical Device Prototypes in Adult Patients With Dry Eye Syndrome
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device to treat dry eye patients
- Conditions
- Dry Eye Syndrome
- Being tested
- Lacrima medical Prototypes
- Keywords
- Keratoconjunctivitis Sicca, Dry Eye Syndromes
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacrima medical PrototypesDevice
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Lacrima medical device | Experimental | Not described Receives: Device: Lacrima medical Prototypes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Tear Meniscus Height using Optical Coherence Tomography
Measured: up to 8 hours
Secondary outcomes (1)
Visual Analog Scale score
Measured: up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startFeb 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Why it stopped: Sponsor decision due to change the clinical indication to Chronic Insomnia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lacrima Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957670
- Sponsor's protocol ID
- LM001
- Status last verified
- Mar 2016
- First submitted
- 30 Sep 2013
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot, Open-label, Single-Arm Study Designed to Clinically Evaluate Various Lacrima Medical Device Prototypes in Adult Patients With Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT01957670
- Acronym / sponsor ID
- LM001
- Conditions
- Dry Eye Syndrome
- Keywords
- Keratoconjunctivitis Sicca, Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision due to change the clinical indication to Chronic Insomnia
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lacrima Medical LTDIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 8 Oct 2013 (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.
The study will assess the safety, tolerability and feasibility of Lacrima investigational medical device to treat dry eye patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Lacrima medical device | Experimental | Device: Lacrima medical Prototypes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Lacrima medical Prototypes | Device | Treatment with Lacrima medical device |
Primary outcome
Lower Tear Meniscus Height using Optical Coherence Tomography
Time frame: up to 8 hours
1 secondary outcome
Visual Analog Scale score
Time frame: up to 8 hours
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 8 Mar 2016.
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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 study testing Lacrima medical Prototypes in people with Dry Eye Syndrome, run by Lacrima Medical LTD at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 Mar 2016. 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 Israel. 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?
Lower Tear Meniscus Height using Optical Coherence Tomography (time frame: up to 8 hours). 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 8 Mar 2016.