Study of SY-201 Ophthalmic Solution in Subjects With Dry Eye Disease

Seinda Pharmaceutical Guangzhou

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dry Eye Disease

Treatments: Drug: SY-201 Ophthalmic Solution 0.5%; Drug: SY-201 Ophthalmic Solution 1.0%; Drug: SY-201 Ophthalmic Solution 2.0%; Drug: SY-201 Ophthalmic Solution Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT05370495

SY201-CS201

Details and patient eligibility

About

This is a phase 2, multi-center, double-masked, randomized, vehicle-controlled, dose-response, parallel-group study designed to evaluate the safety and tolerability and ocular efficacy of SY-201 Ophthalmic Solution versus vehicle over a 60-day treatment period in subjects with dry eye disease (DED).

Enrollment: 201 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria

  1. Provide written informed consent prior to any study-related procedures.
  2. Are 18 years of age or older.
  3. Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.
  4. Have a Best Corrected Visual Acuity (BCVA) in each eye, using corrective lenses if necessary, of +0.7 logarithm of the minimum angle of resolution (LogMAR) or better as assessed by the Early Treatment of Diabetic Retinopathy Study (ETDRS) at Visit 1.

Exclusion Criteria:

1. Unanesthetized Schirmer test score in either eye <2 mm/5 minutes at Visit 1.
2. Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications at the time of entry into the study that could interfere in the assessment of the trial
3. Have corneal erosive disease (e.g., confluent staining [National Eye Institute (NEI) grade 4], confluent filaments) or other conditions suggestive of extensive damage of the cornea in either eye.
4. Have a history of glaucoma or intraocular pressure (IOP) >25 mmHg at Visit 1 or a history of elevated IOP (>25 mmHg) in either eye.
5. Wear contact lenses for 14 days prior to Visit 1 or throughout the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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201 participants in 4 patient groups, including a placebo group

SY-201 Ophthalmic Solution 2.0%

Experimental group

Description:

SY-201 Ophthalmic Solution 2.0%

Treatment:

Drug: SY-201 Ophthalmic Solution 2.0%

SY-201 Ophthalmic Solution 1.0%

Experimental group

Description:

SY-201 Ophthalmic Solution 1.0%

Treatment:

Drug: SY-201 Ophthalmic Solution 1.0%

SY-201 Ophthalmic Solution 0.5%

Experimental group

Description:

SY-201 Ophthalmic Solution 0.5%

Treatment:

Drug: SY-201 Ophthalmic Solution 0.5%

SY-201 Ophthalmic Solution Vehicle

Placebo Comparator group

Description:

SY-201 Ophthalmic Solution Vehicle

Treatment:

Drug: SY-201 Ophthalmic Solution Vehicle