Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • STN1013800 ophthalmic solution

    Drug

    Investigational Product: 0.1% STN1013800 ophthalmic solution

  • STN1013800 ophthalmic solution Liquid Base, without STN1013800

    Drug

    Placebo control: STN1013800 ophthalmic solution Liquid Base, without STN1013800

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: STN1013800 ophthalmic solutionExperimental treatment 1 intervention
Group B: STN1013800 ophthalmic solution Liquid Base, without STN1013800Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mean change from Baseline in the STN1013800 group versus the Vehicle (Placebo) group

Mean change from Baseline (Day 1, Hour 0) in the STN1013800 group versus the Vehicle (Placebo) group in number of points seen in the top 4 rows on the Leicester Peripheral Field Test (LPFT test) at 2 time points

Time frame
Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)

Secondary outcomes

1

Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group

Mean change of MRD-1 from Baseline (Day 1, Hour 0) in the STN1013800 group versus the Vehicle (Placebo) group at 2 time points

Time frame
Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)
2

Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group

Mean change of MRD-1 from Baseline (Day1, Hour 0) in the STN1013800 group versus the Vehicle (Placebo) group at other timepoints

Time frame
Day 1 at Minute 5, Minute 15, Hour 2; Day 14 at Minute 5, Minute 15, Hour 6; Day 42 at Minute 5, Minute 15

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Santen Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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