Dry Eye SyndromeNCT00535054
Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms
A study testing Tears Again in people with Dry Eye Syndrome, run by Trima, Israel Pharmaceutical Products at 1 site in Israel.
Trial summary
The purpose of this study is to determine safety and patients' satisfaction when using Tears Again to treat Dry Eye Symptoms. Read more about this study
- Who is it for?
- Ages 25 to 85 years
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Tears Again
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2007to Feb 2010
- 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 25 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suffer from at least two of the following ocular symptoms: burning, stinging, excessive tearing, dryness, grittiness, foreign body sensation ( including patients suffering from blepharitis).
- Use artificial tears or any other treatment for these symptoms three or more times a day.
Who cannot join
- Known hypersensitivity to Phenoxyethanol.
- Pregnant and lactating women.
- Receive other ophthalmic medication (except for eyelid hygiene preparations).
- Graft-versus-host disease patients.
- Participated during the last month in another clinical trial.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Ophthalmology, Assaf Harofeh Medical Center,
Tsrifin
About this study
Official title: An Open Study to Assess the Safety and Patients' Satisfaction Tears Again* in the Treatment of Dry Eye Symptoms
The purpose of this study is to determine safety and patients' satisfaction when using Tears Again to treat Dry Eye Symptoms.
- Conditions
- Dry Eye Syndrome
- Being tested
- Tears Again
- Keywords
- Dry Eye Syndrome
- 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.
Tears AgainDrug
Liposome Eye Spray
| Study group | Role | What they receive |
|---|---|---|
| Tears Again | Experimental | All subjects shall be treated with Tears Again. Receives: Drug: Tears Again |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer Test, Lissamine Green Test and BUT.
Measured: On enrollment and one month later.
Secondary outcomes (1)
Questionaire
Measured: One, three and four weeks after treatment commencement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trima, Israel Pharmaceutical Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Zadok, MD, Principal investigator, Department of Ophthalmology, Assaf Harofeh Medical Center,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535054
- Sponsor's protocol ID
- 06.11
- Status last verified
- Feb 2010
- First submitted
- 23 Sep 2007
- Last updated
- 9 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lee S, Dausch S, Maierhofer G, Dausch D. [A new therapy concept for the treatment of dry eye--the usefulness of phospholipid liposomes]. Klin Monbl Augenheilkd. 2004 Oct;221(10):825-36. doi: 10.1055/s-2004-813715. German.
PubMed 15499517Dausch D, Lee S, Dausch S, Kim JC, Schwert G, Michelson W. [Comparative study of treatment of the dry eye syndrome due to disturbances of the tear film lipid layer with lipid-containing tear substitutes]. Klin Monbl Augenheilkd. 2006 Dec;223(12):974-83. doi: 10.1055/s-2006-927266. German.
PubMed 17199193
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Study to Assess the Safety and Patients' Satisfaction Tears Again* in the Treatment of Dry Eye Symptoms
- ClinicalTrials.gov ID
- NCT00535054
- Acronym / sponsor ID
- 06.11
- Conditions
- Dry Eye Syndrome
- Keywords
- Dry Eye Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Trima, Israel Pharmaceutical ProductsIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 26 Sep 2007 (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 purpose of this study is to determine safety and patients' satisfaction when using Tears Again to treat Dry Eye Symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tears Again | Experimental | Drug: Tears AgainAll subjects shall be treated with Tears Again. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suffer from at least two of the following ocular symptoms: burning, stinging, excessive tearing, dryness, grittiness, foreign body sensation ( including patients suffering from blepharitis).
- Use artificial tears or any other treatment for these symptoms three or more times a day.
Key exclusion criteria (5 listed)
- Known hypersensitivity to Phenoxyethanol.
- Pregnant and lactating women.
- Receive other ophthalmic medication (except for eyelid hygiene preparations).
- Graft-versus-host disease patients.
- Participated during the last month in another clinical trial.
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 |
|---|---|---|
| Tears AgainLiposome Eye Spray | Drug | Tears Again |
Primary outcome
Schirmer Test, Lissamine Green Test and BUT.
Time frame: On enrollment and one month later.
1 secondary outcome
Questionaire
Time frame: One, three and four weeks after treatment commencement.
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 9 Feb 2010.
- Background: PubMed 15499517Lee S, Dausch S, Maierhofer G, Dausch D. [A new therapy concept for the treatment of dry eye--the usefulness of phospholipid liposomes]. Klin Monbl Augenheilkd. 2004 Oct;221(10):825-36. doi: 10.1055/s-2004-813715. German.
- Background: PubMed 17199193Dausch D, Lee S, Dausch S, Kim JC, Schwert G, Michelson W. [Comparative study of treatment of the dry eye syndrome due to disturbances of the tear film lipid layer with lipid-containing tear substitutes]. Klin Monbl Augenheilkd. 2006 Dec;223(12):974-83. doi: 10.1055/s-2006-927266. German.
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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.
David Zadok, MD principal investigator
Department of Ophthalmology, Assaf Harofeh Medical Center,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tears Again in people with Dry Eye Syndrome, run by Trima, Israel Pharmaceutical Products 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?
The sponsor lists 2 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 9 Feb 2010. 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 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?
Schirmer Test, Lissamine Green Test and BUT. (time frame: On enrollment and one month later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00535054, which also lists 2 linked publications.
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 9 Feb 2010.