Efficacy, Safety of T2769 in Dry Eye Disease

• Sponsor: Laboratoires Thea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03830359
• Collaborator: (none)
• Enrollment: 62
• Locations: 3
• Arm: 1
• Actual Duration (Months): 5.6
• Patients Per Site: 20.7
• Patients Per Site Per Month: 3.7

Study Details

Study Description

Brief Summary

Efficacy of T2769 in Dry Eye Desease

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Other: T2769	N/A

Detailed Description

Multicenter and open study

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Efficacy and Safety Assessment of T2769 in Patients With Moderate to Severe Dry Eye Syndrome
• Actual Study Start Date: Sep 1, 2018
• Actual Primary Completion Date: Feb 18, 2019
• Actual Study Completion Date: Feb 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: T2769 T2769 Ophthalmic solution patients treated with 1 drop in each eye 3 to 6 times daily	Other: T2769; At least 55 enrolled patients for at least 50 evaluable patients treated by T2769 for 42 days; Other Names: Ophthalmic solution

Outcome Measures

Primary Outcome Measures

1. Ocular Symptomatology [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• Best far corrected visual acuity ≤ 2/10

• Severe blepharitis Severe dry eye

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Universitaire Tahar Sfar	Mahdia		Tunisia	5100
2	"Hôpital Universitaire Fattouma Bourguiba	Monastir		Tunisia	5000
3	"Hôpital de Forces de Sécurité Intérieure La Marsa	Tunis		Tunisia

Sponsors and Collaborators

• Laboratoires Thea

Investigators

• Principal Investigator: Lamia El Fekih, Pr, [e-mail]

Study Documents (Full-Text)

• Study Protocol - Nov 13, 2017
• Statistical Analysis Plan - Jul 4, 2019

More Information

Publications

None provided.

• Responsible Party: Laboratoires Thea
• ClinicalTrials.gov Identifier: NCT03830359
• Other Study ID Numbers: LT2769-001
• First Posted: Feb 5, 2019
• Last Update Posted: Mar 16, 2022
• Last Verified: Aug 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome; Ophthalmic Solutions

Study Results

Participant Flow

Arm/Group Title	T2769
Arm/Group Description	T2769 : 1 drop in each eye 3 to 6 times daily during 42 days
Period Title: Overall Study
STARTED	62
COMPLETED	62
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	T2769
Arm/Group Description	T2769 Ophthalmic solution One drop in each eye 3 to 6 times daily T2769: 62 patients treated by T2769 for 42 days
Overall Participants	62
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	51 82.3%
>=65 years	11 17.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.4 (11.8)
Sex: Female, Male (Count of Participants)
Female	53 85.5%
Male	9 14.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	0 0%
More than one race	0 0%
Unknown or Not Reported	62 100%
Region of Enrollment (participants) [Number]
Tunisia	62 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	T2769
Arm/Group Description	T2769 Ophthalmic solution One drop in each eye 3 to 6 times daily T2769: 62 patients treated by T2769 for 42 days
Measure Participants	62
Mean (Standard Deviation) [units on a scale]	-55.9 (23.1)

Adverse Events

Time Frame	3 months
Arm/Group Title	T2769
Arm/Group Description	T2769 Ophthalmic solution One drop in each eye 3 to 6 times daily of T2769 for 42 days
All Cause Mortality
	T2769
	Affected / at Risk (%)	# Events
Total	0/62 (0%)
Serious Adverse Events
	T2769
	Affected / at Risk (%)	# Events
Total	0/62 (0%)
Other (Not Including Serious) Adverse Events
	T2769
	Affected / at Risk (%)	# Events
Total	0/62 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.