RecruitingPhase 3

LIDRISE Study: A Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops, Single Dose) in the Treatment of Acquired Blepharoptosis.

Czechia, France234 participantsStarted 2024-12-30

Plain-language summary

A Randomised, Double-Masked, Placebo-Controlled Phase 3 Study on the Efficacy and Safety of STN1013800 (Oxymetazoline HCl 0.1% Eye Drops) used twice daily (BID) in the Treatment of Acquired Blepharoptosis

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. diagnosis of acquired ptosis in both eyes with MRD 1 ≥0 and ≤ 2 mm in the study eye
✓. Snellen VA of 20/80 or better in both eyes Note: MRD1 is defined as the distance between upper eye lid margin and centre of the pupil. MRD0 is defined as the upper eye lid margin at the centre of the pupil. Measurement of MRD1 will be done by a Central Reading Centre. If the centre of the pupil cannot be determined by the Central Reading Centre due to negative MRD1, the subject will be deemed ineligible.

Exclusion criteria

✕. Pseudo ptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin); or
✕. Dermatochalasis that extends less than 3 mm above the upper eyelid margin.

What they're measuring

Change from baseline in Marginal Reflex Distance (MRD1) on Day 14 at 4 hours after PM dose.

Timeframe: Day 14 at 4 hours

Trial details

NCT IDNCT06514612

SponsorSanten SAS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-01

Contact for this trial

Santen SAS Clinical Operations

+31 683 667 357 edith.vandijkman@santen.com

View on ClinicalTrials.gov More Acquired Blepharophimosis trials