NCT03830359

Brief Summary

Efficacy of T2769 in Dry Eye Desease

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2019

Completed
3 years until next milestone

Results Posted

Study results publicly available

March 4, 2022

Completed
Last Updated

March 16, 2022

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

January 7, 2019

Results QC Date

September 18, 2020

Last Update Submit

March 8, 2022

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

  • Ocular Symptomatology

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

    Baseline and Day 42

Study Arms (1)

T2769

EXPERIMENTAL

T2769 Ophthalmic solution patients treated with 1 drop in each eye 3 to 6 times daily

Other: T2769

Interventions

T2769OTHER

At least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days

Also known as: Ophthalmic solution
T2769

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hôpital Universitaire Tahar Sfar

Mahdia, 5100, Tunisia

Location

"Hôpital Universitaire Fattouma Bourguiba

Monastir, 5000, Tunisia

Location

"Hôpital de Forces de Sécurité Intérieure La Marsa

Tunis, Tunisia

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Results Point of Contact

Title
ESTRADE
Organization
Laboratoires Thea
marielle.estrade@theapharma.com
0635156453

Study Officials

  • Lamia El Fekih, Pr

    fekihlamia63@gmail.com

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2019

First Posted

February 5, 2019

Study Start

September 1, 2018

Primary Completion

February 18, 2019

Study Completion

February 18, 2019

Last Updated

March 16, 2022

Results First Posted

March 4, 2022

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(3)