Dry Eye SyndromesPhase 3NCT01568593
Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
A Phase 3 study testing T2750 and Vismed in people with Dry Eye Syndromes, run by Laboratoires Thea at 1 site in France.
Trial summary
Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- T2750 and Vismed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2012to Mar 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed and dated informed consent
- Male or female aged from ≥ 18 years old.
- Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.
Who cannot join
- Best far corrected visual acuity < 1/10
- Severe blepharitis
- Severe Dry Eye
- Eyelid malposition
- Known hypersensitivity to one of the components of the study medications or test products.
- Pregnant or breast-feeding woman.
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- Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms).
- Inability of patient to understand the study procedures and thus inability to give informed consent.
- Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance).
- Already included once in this study.
- Patient under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
- Conditions
- Dry Eye Syndromes
- Being tested
- T2750, Vismed
- 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.
T2750Device
1 drop in each eye 3 to 6 times daily during 84 days
VismedDevice
1 drop in each eye 3 to 6 times daily during 84 days
| Study group | Role | What they receive |
|---|---|---|
| T2750 | Experimental | Not described Receives: Device: T2750 |
| Vismed | Active comparator | Not described Receives: Device: Vismed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Ocular Staining (With Oxford Scale - Ranges :0-15)
Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)
Measured: Baseline and 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye SyndromesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01568593
- Sponsor's protocol ID
- LT2750-PIII-10/11
- Status last verified
- Oct 2014
- First submitted
- 29 Mar 2012
- Last updated
- 4 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of T2750 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT01568593
- Acronym / sponsor ID
- LT2750-PIII-10/11
- Conditions
- Dry Eye Syndromes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 2 Apr 2012 (estimated)
- Results
- Posted 27 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2750 | Experimental | Device: T2750 |
| Vismed | Active comparator | Device: Vismed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed and dated informed consent
- Male or female aged from ≥ 18 years old.
- Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.
Key exclusion criteria (11 listed)
- Best far corrected visual acuity < 1/10
- Severe blepharitis
- Severe Dry Eye
- Eyelid malposition
- Known hypersensitivity to one of the components of the study medications or test products.
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 |
|---|---|---|
| T27501 drop in each eye 3 to 6 times daily during 84 days | Device | T2750 |
| Vismed1 drop in each eye 3 to 6 times daily during 84 days | Device | Vismed |
Primary outcome
Global Ocular Staining (With Oxford Scale - Ranges :0-15)
Time frame: Baseline and 35 days
Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Phase 3 study testing T2750 and Vismed in people with Dry Eye Syndromes, run by Laboratoires Thea at 1 site in France.
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 11 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 4 Apr 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Global Ocular Staining (With Oxford Scale - Ranges :0-15) (time frame: Baseline and 35 days). 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 4 Apr 2016.