A Study in Chinese Patients With Acquired Blepharoptosis
ConditionBlepharoptosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSanten Pharmaceutical Co., Ltd.
About this trial
This is a Phase III Study to evaluate the efficacy and safety of STN1013800 Ophthalmic Solution in Chinese Patients with Acquired Blepharoptosis.
At present, there are no medicines for the treatment of acquired blepharoptosis in China.
Therefore, to evaluate the efficacy and safety of 0.1% STN1013800 ophthalmic solution, Vehicle (Placebo) are designed.
For the screening period, 3-7 days were set to confirm the subjects and judge their qualification. Dosage and administration were based on prior clinical trial results approved at 0.1% once daily for 42 days treatment.
Eligibility criteria
Qualifiers
Loss of reliable Leicester Peripheral Field Test (LPFT) of ≥ 8 points in the top 2 rows (LPFT Eligibility Score); subjects had to see at least 9 total points in the top 4 rows (LPFT Total Score).
This criterion had to be met in both the Visit 1 Hour 0 (V1H0) and Visit 1 Hour 6 (V1H6) LPFT assessments.
There had to be ≤4 points of variance between the V1H0 and the V1H6 LPFT Eligibility Score.
The Marginal Reflex Distance-1 (MRD-1), the distance from the pupil center to the margin of upper lid, ≤ 2 mm (no visible pupil center defaults to 0) in the same eye
Disqualifiers
Dermatochalasis that extended less than 3 mm above the upper eyelid margin.
Pseudoptosis (upper eyelid dermatochalasis that overhung the upper eyelid margin).
In either eye: Congenital ptosis; Horner syndrome; Marcus Gunn jaw-winking syndrome; Myasthenia gravis.
Mechanical ptosis, including ptosis due to orbital or lid tumour, cicatricial processes affecting the movements of the upper lid, and enophthalmos.
Trial design
Treatments tested in this trial
- STN1013800 ophthalmic solution
- STN1013800 ophthalmic solution Liquid Base, without STN1013800
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov