A phase II dose-response study to assess the safety and efficacy of SJP-0035 in patients with corneal epithelial disorder

A phase II dose-response study to assess the safety and efficacy of SJP-0035 in patients with corneal epithelial disorder - A phase II dose-response study to assess the safety and efficacy of SJP-0035 in patients with corneal epithelial disorder

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000034199

Enrollment

Registered

2018-09-19

Start date

2018-09-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal epithelial disorder

Interventions

One drop of SJP-0035 is instilled four times daily for 28 days. One drop of SJP-0035 is instilled four times daily for 28 days. One drop of placebo is instilled four times daily for 28 days.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Written informed consent obtained after adequate explanation on participating the study 2)Male or female outpatients, 20 years of age or older 3)Patients with corneal epithelial disorders caused by Sjogren syndrome, tear dysfunction or diabetic keratopathy 4)Patients with moderate to severe corneal epithelial disorders in the central zone 5)Patients with blurred vision caused by corneal epithelial disorders

Exclusion criteria

Exclusion criteria: 1)Patients with prior ocular instillation of SJP-0035 2)Patients who currently have punctal occlusions inserted or with surgical punctal closure 3)Patients with best corrected visual acuity =< 0.2 4)Patients with corneal stromal or endothelial abnormalities including an active bacterial or viral ocular infection, bullous keratopathy, chemical burns, or any trauma to the cornea 5)Patients with any active or chronic allergic, bacterial, or viral infection of ocular adnexa and eye structures 6)Patients with removal of punctal occlusions within the last 14 days 7)Patients with previous intraocular surgery within the last 28 days 8)Patients with previous refractive surgery within the last 180 days 9)Patients with use of any ocular medication within the last 28 days 10)Patients who need the treatment for possibly improving ocular symptoms such as eye wash, lid hygiene, warm compress or massage, in either eye within 14 days prior to the first dose of study drug through the duration of the study 11)Patients who has a known hypersensitivity or significant adverse drug reaction to PPAR agonists, related compounds or any ingredients of drugs used in this study 12)Presence of a cancer or a serious systemic disease

Design outcomes

Primary

Measure	Time frame
Change in corneal fluorescein staining from the baseline of treatment at week 5	—

Countries

Japan

Contacts

Public ContactTakuro Sekiya

Senju Pharmaceutical Co.,Ltd. Clinical Development

t-sekiya@senju.co.jp06-6201-9605

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026