Dry Eye SyndromeNCT03830359

Efficacy, Safety of T2769 in Dry Eye Disease

A study testing T2769 in people with Dry Eye Syndrome, run by Laboratoires Thea at 3 sites in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Efficacy of T2769 in Dry Eye Desease 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?: T2769
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 62 participants
Where: 3 sitesTunisia
Study dates: 1 Sep 2018to 18 Feb 2019
Phase: Interventional
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 screening

Who cannot join

Best far corrected visual acuity ≤ 2/10
Severe blepharitis Severe dry eye

Trial locations and contacts

3 sites in 1 country.

Tunisia3 sites

Hôpital Universitaire Tahar Sfar
Mahdia, 5100
"Hôpital Universitaire Fattouma Bourguiba
Monastir, 5000
"Hôpital de Forces de Sécurité Intérieure La Marsa
Tunis

Other trials in Tunisia

About this study

Official title: Efficacy and Safety Assessment of T2769 in Patients With Moderate to Severe Dry Eye Syndrome

Efficacy of T2769 in Dry Eye Desease

Read the detailed description

Multicenter and open study

Conditions: Dry Eye Syndrome
Being tested: T2769
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.

T2769Other
Also called Ophthalmic solution
At least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days

Study groups in NCT03830359
Study group	Role	What they receive
T2769	Experimental	T2769 Ophthalmic solution patients treated with 1 drop in each eye 3 to 6 times daily Receives: Other: T2769

What is being measured

The primary outcome is the main question the study is designed to answer.

Ocular Symptomatology
Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42.
Measured: Baseline and Day 42

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201818 Feb 2019

First posted5 Feb 2019
Study start1 Sep 2018
Primary completion18 Feb 2019
Study completion18 Feb 2019

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 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: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03830359
Sponsor's protocol ID: LT2769-001
Status last verified: Aug 2019
First submitted: 7 Jan 2019
Last updated: 16 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety Assessment of T2769 in Patients With Moderate to Severe Dry Eye Syndrome
ClinicalTrials.gov ID: NCT03830359
Acronym / sponsor ID: LT2769-001
Conditions: Dry Eye Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Laboratoires TheaIndustry (pharma, biotech, devices)
Study start: 1 Sep 2018 (actual)
Primary completion: 18 Feb 2019 (actual)
Study completion: 18 Feb 2019 (actual)
First posted: 5 Feb 2019 (actual)
Results: Posted 4 Mar 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Efficacy of T2769 in Dry Eye Desease

Detailed description

Multicenter and open study

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
T2769	Experimental	Other: T2769T2769 Ophthalmic solution patients treated with 1 drop 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 from ≥ 18 years old
Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study screening

Key exclusion criteria (2 listed)

Best far corrected visual acuity ≤ 2/10
Severe blepharitis Severe dry eye

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
T2769Also: Ophthalmic solutionAt least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days	Other	T2769

Primary outcome

Ocular Symptomatology
Time frame: Baseline and Day 42
Change from baseline in ocular symptomatology on a Visual Analog Scale (0=No discomfort and 100=Maximal discomfort) at Day 42.

Results and safety

Results posted to the registry on 4 Mar 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
T2769	62	62

Primary outcome: Ocular Symptomatology

Time frame: Baseline and Day 42. Mean (Standard Deviation). Unit: units on a scale

Measure	T2769 n = 62
Value	-55.9 (23.1)

Population analysed: m-ITT population : all enrolled patients having received at least one dose of the IP and with at least one baseline and post-baseline efficacy assessment.

Adverse events

Time frame: 3 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
T2769	0 of 62 (0%)	0 of 62 (0%)	0 of 62

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Dry Eye Syndrome

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Sjogren's Syndrome, Sjögren
RecruitingPhase 1
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Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
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Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
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Not yet recruitingPhase 2
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Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)

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.

Lamia El Fekih, Pr principal investigator

fekihlamia63@gmail.com

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing T2769 in people with Dry Eye Syndrome, run by Laboratoires Thea at 3 sites in Tunisia.

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 2 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 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Tunisia. 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?

Yes. Results are posted in the registry (first posted 4 Mar 2022). 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?

Ocular Symptomatology (time frame: Baseline and Day 42). 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 NCT03830359.

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 16 Mar 2022.