Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.

Dry Eye Clinical Trial

Official title:

Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05931861
• Other study ID #: LT2769-003
• Status: Completed
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: December 4, 2023

Study information

• Verified date: September 2023
• Source: Laboratoires Thea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a confirmatory clinical investigation. The objective is to collect new additional clinical data demonstrating the safety and performance of the device in the contact-lens wearing population with dry eyes. The hypotheses are that T2769 improves dry eye symptomatology (e.g. decrease in CLDEQ-8 score, in OSDI score, ocular discomfort assessed by VAS) and signs (e.g. increase in Schirmer and TBUT, decrease in Oxford score) at D36, in comparison to baseline. The primary objective of this investigation is to assess the performance of T2769 in contact lens wearers with dry eye symptoms in terms of change from baseline (Day 1) to Day 36 (Final visit) in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 4, 2023
• Est. primary completion date: December 4, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Main Inclusion Criteria:

• Informed consent signed and dated
• Patient aged = 18 years old
• Well fitted contact lenses (CL) according to the investigator judgement
• Daily wearer of any type of CL for a minimum of 5 days/week for 6 hours/day over at least the last month and is willing to continue to do so during the study
• Patient with an Ocular Surface Disease Index (OSDI) score = 18
• CLDEQ-8 score = 12

Main Exclusion Criteria:

• Far Best-Corrected Visual Acuity (BCVA) =+0.7 LogMar (e.g., =0.2 in decimal value or =20/100 Snellen equivalent or =50 ETDRS letters).
• Severe blepharitis
• Severe Meibomian gland dysfunction
• Palpebral or nasolacrimal disorders
• Dry eye associated with at least one of the following diseases/symptoms: ocular rosacea, Pterygium, Eyelid malposition, Corneal dystrophy, Ocular neoplasia, Filamentous keratitis, Corneal neovascularisation, Orbital radiotherapy, Cataract, Retinal disease.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• T2769
T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.

Locations

Country	Name	City	State
Bulgaria	Medical Center "Oxycom"	Burgas
Bulgaria	"Asmp Ob - Ip Glm" Eood	Smolyan
Bulgaria	Medical Center For Eye Health "Focus"	Sofia
Bulgaria	Specialized Ophthalmological Hospital For Active Treatment "Pentagram"	Sofia
Bulgaria	Medical Center "Vereya"	Stara Zagora
Bulgaria	Ambulatory For Group Practice For Specialized Medical Care For Eye Diseases - Dr. Grupchevi	Varna

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoires Thea

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.	The primary endpoint is the change from baseline (Day 1) to Day 36 in the CLDEQ-8 total score.; CLDEQ-8 consists of 8 questions designed to measure dry eye symptoms specifically related to the use of contact lenses. The total score is obtained by adding the scores obtained for each answer. The final score is ranging from 1 to 37.	CLDEQ- score is assessed at Day 1 and Day 36