Dry Eye SyndromeNCT02617095
Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome
A study testing T2762 and Optive in people with Dry Eye Syndrome, run by Laboratoires Thea at 1 site in France.
Trial summary
The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® 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 Syndrome
- What is being tested?
- T2762 and Optive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Oct 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 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 ≥ 18 years old.
- Diagnosis of moderate to severe dry eye syndrome
Who cannot join
- Pregnancy, lactation.
- Childbearing potential woman who is not using a reliable method of contraception and is not surgically sterilised.
- Inability of patient to understand the study procedures and thus inability to give informed consent.
- Non-compliant patient
- Participation in another clinical study at the same time as the present study.
- Participation to the present study during the exclusion period of another clinical study.
Show all 9Show fewer
- Already included once in this study.
- Ward of court.
- Patient not covered by government health care scheme
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® in the treatment of moderate to severe Dry Eye Syndrome.
- Conditions
- Dry Eye Syndrome
- Being tested
- T2762, Optive
- 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.
T2762Device
One drop in each eye 3 to 6 times daily
OptiveDevice
One drop in each eye 3 to 6 times daily
| Study group | Role | What they receive |
|---|---|---|
| T2762 | Experimental | One drop of T2762 in each eye 3 to 6 times daily Receives: Device: T2762 |
| Optive | Active comparator | One drop of Optive in each eye 3 to 6 times daily Receives: Device: Optive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the symptomatology evaluation on a Visual Analogic Scale
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2016
- Study completionOct 2016
Why it stopped: recruitment rate too slow
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires Thea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Larkin, Professor, Principal investigator, Moorfields Eye Hospital -162 city road - LondonFriedrich KRUSE, Professor, Principal investigator, Augenklinik mit Poliklinik - Swabachanlage 6 - 91054 Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617095
- Sponsor's protocol ID
- LT2762-PIV-11/13
- Status last verified
- Mar 2017
- First submitted
- 26 Nov 2015
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT02617095
- Acronym / sponsor ID
- LT2762-PIV-11/13
- Conditions
- Dry Eye Syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment rate too slow
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Laboratoires TheaIndustry (pharma, biotech, devices)
- Study start
- Feb 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 Nov 2015 (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 compare the efficacy and safety of T2762 versus Optive® 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 |
|---|---|---|
| T2762 | Experimental | Device: T2762One drop of T2762 in each eye 3 to 6 times daily |
| Optive | Active comparator | Device: OptiveOne drop of Optive in each eye 3 to 6 times daily |
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 ≥ 18 years old.
- Diagnosis of moderate to severe dry eye syndrome
Key exclusion criteria (9 listed)
- Pregnancy, lactation.
- Childbearing potential woman who is not using a reliable method of contraception and is not surgically sterilised.
- Inability of patient to understand the study procedures and thus inability to give informed consent.
- Non-compliant patient
- Participation in another clinical study at the same time as the present study.
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 |
|---|---|---|
| T2762One drop in each eye 3 to 6 times daily | Device | T2762 |
| OptiveOne drop in each eye 3 to 6 times daily | Device | Optive |
Primary outcome
Change of the symptomatology evaluation on a Visual Analogic Scale
Time frame: Day 28
Results and safety
The study was stopped early (reason given: recruitment rate too slow). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2017.
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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.
Frank Larkin, Professor principal investigator
Moorfields Eye Hospital -162 city road - London
Friedrich KRUSE, Professor principal investigator
Augenklinik mit Poliklinik - Swabachanlage 6 - 91054 Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T2762 and Optive in people with Dry Eye Syndrome, 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 9 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: stopped early, as of the sponsor's last update on 8 Mar 2017. 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.
Are results available for this study?
The study was stopped early (reason given: recruitment rate too slow). Results are not available in the source record.
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?
Change of the symptomatology evaluation on a Visual Analogic Scale (time frame: Day 28). 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 2017.