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.

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSanten SAS

About this trial

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

Eligibility criteria

Qualifiers

Able to understand and sign an informed consent form prior to participation in any studyrelated procedures.

Male or female subjects ≥ 18 years and ≤ 75 years.

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.

Disqualifiers

Congenital ptosis.

Pseudo ptosis (upper eyelid dermatochalasis that overhangs the upper eyelid margin); or

Dermatochalasis that extends less than 3 mm above the upper eyelid margin.

Neurogenic ptosis (e.g., Horner's syndrome, 3rd cranial nerve palsy).

Trial design

Treatments tested in this trial

  • STN1013800 (0.1% Oxymetazoline Hydrochloride) eye drops in single dose containers
  • Placebo (0% Oxymetazoline Hydrochloride) eye drops in single dose containers

Treatment groups

234 Participants
are divided into 2 treatment groups

Sponsors and collaborators