Back to resultsPerformance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.
Primary Purpose
Dry Eye
Status
Recruiting
Phase
Not Applicable
Locations
Bulgaria
Study Type
Interventional
Intervention
T2769
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye
Eligibility Criteria
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.
Sites / Locations
- Medical Center "Oxycom"Recruiting
- "Asmp Ob - Ip Glm" EoodRecruiting
- Medical Center For Eye Health "Focus"Recruiting
- Specialized Ophthalmological Hospital For Active Treatment "Pentagram"
- Medical Center "Vereya"Recruiting
- Ambulatory For Group Practice For Specialized Medical Care For Eye Diseases - Dr. GrupcheviRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
T2769
Arm Description
One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05931861
Brief Title
Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.
Official Title
Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoires Thea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
T2769
Arm Type
Experimental
Arm Description
One drop in each eye, from 3 to 6 times daily, at any time but only when patients are wearing their contact lenses.
Intervention Type
Device
Intervention Name(s)
T2769
Intervention Description
T2769: sodium hyaluronate 0.15%, Trehalose 3%, Naaga 2.45% in a 12.5 mL ABAK® multi-dose bottle.
Primary Outcome Measure Information:
Title
Change from baseline in Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) total score.
Description
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.
Time Frame
CLDEQ- score is assessed at Day 1 and Day 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corentin LE CAMUS
Phone
+33473981436
Email
Corentin.LECAMUS@theapharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Grupcheva, Professor
Organizational Affiliation
Individual Practice for Specialized Ophthalmology Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Center "Oxycom"
City
Burgas
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
"Asmp Ob - Ip Glm" Eood
City
Smolyan
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center For Eye Health "Focus"
City
Sofia
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Specialized Ophthalmological Hospital For Active Treatment "Pentagram"
City
Sofia
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Name
Medical Center "Vereya"
City
Stara Zagora
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Ambulatory For Group Practice For Specialized Medical Care For Eye Diseases - Dr. Grupchevi
City
Varna
Country
Bulgaria
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Performance and Safety Assessment of T2769 in Contact Lens Wearers With Dry Eye Symptoms.
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