Efficacy of T2259 in DED

Thea Pharma

Status: Completed

Conditions: Dry Eye Syndromes

Treatments: Device: T2259; Device: Vismed multi

Study type: Interventional

Funder types: Industry

Identifiers

NCT03874429

LT2259-001

Details and patient eligibility

About

The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main 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

Main exclusion Criteria:

• Far best-corrected visual acuity≤2/10
• Severe Blepharitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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101 participants in 2 patient groups

T2259

Experimental group

Description:

1 drop in each eye 2 to 4 times daily

Treatment:

Device: T2259

Vismed Multi

Active Comparator group

Description:

1 drop in each eye 2 to 4 times daily

Treatment:

Device: Vismed multi