Dry Eye Syndromes
Conditions
Brief summary
Comparison of the efficacy and safety of T2750 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
Interventions
DEVICET2750
1 drop in each eye 3 to 6 times daily during 84 days
DEVICEVismed
1 drop in each eye 3 to 6 times daily during 84 days
Sponsors
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 selection.
Exclusion criteria
* Best far corrected visual acuity \< 1/10 * Severe blepharitis * Severe Dry Eye * Eyelid malposition * Known hypersensitivity to one of the components of the study medications or test products. * Pregnant or breast-feeding woman. * Woman of childbearing age (neither menopausal, nor hysterectomised, nor sterilized) not using effective contraception (oral contraceptives, intra-uterine device, contraceptive implant or condoms). * Inability of patient to understand the study procedures and thus inability to give informed consent. * Non compliant patient (e.g. not willing to attend the follow-up visits, way of life interfering with compliance). * Already included once in this study. * Patient under guardianship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Ocular Staining (With Oxford Scale - Ranges :0-15) | Baseline and 35 days | Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome) |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| T2750 T2750: 1 drop in each eye 3 to 6 times daily during 84 days | 48 |
| Vismed Vismed: 1 drop in each eye 3 to 6 times daily during 84 days | 45 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 2 |
| Overall Study | Lack of Efficacy | 4 | 1 |
Baseline characteristics
| Characteristic | T2750 | Vismed | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 11.2 | 63.6 years STANDARD_DEVIATION 10 | 62.8 years STANDARD_DEVIATION 10.6 |
| Sex: Female, Male Female | 40 Participants | 38 Participants | 78 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
| Time from the dry eye diagnosis | 7.18 years STANDARD_DEVIATION 6.98 | 6.2 years STANDARD_DEVIATION 5.41 | 6.71 years STANDARD_DEVIATION 6.25 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 45 |
| serious Total, serious adverse events | 1 / 48 | 0 / 45 |
Outcome results
Primary
Global Ocular Staining (With Oxford Scale - Ranges :0-15)
Change from baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome)
Time frame: Baseline and 35 days
Population: Per Protocol Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T2750 | Global Ocular Staining (With Oxford Scale - Ranges :0-15) | -1.8 scores on a scale | Standard Deviation 2.2 |
| Vismed | Global Ocular Staining (With Oxford Scale - Ranges :0-15) | -2 scores on a scale | Standard Deviation 1.4 |