Safety evaluation of albumin eye drop in patients with dry eye disease

Safety evaluation of albumin eye drop in patients with dry eye disease - Safety evaluation of albumin eye drop

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019291

Enrollment

Registered

2015-12-01

Start date

2015-12-01

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

dry eye disease

Interventions

topical recombinant human serum albumin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Over 20 years 2 Definite dry eye disease diagnosed by Japanese dry eye diagnostic criteria 3 Severity of dry eye; Level 1- Level 4 Dry Eye WorkShop 2007 (DEWS 2007)

Exclusion criteria

Exclusion criteria: 1 Severe systemic disease that may progress to more severe condition 2 Sjogren's syndrome, Ocular cicatricial pemphigoid, Graft-versus-host disease (GVHD) 3 History of eye surgery 4 Contact lens wearer 5 Irradiation during this clinical study 6 Oral treatment by Cevemeline and Pilocalpine 7 History of allergy on human serum protein or yeastferment 8 History of allergies to (1) substances contained recombinant materials, eye drops, and the investigational drug, and (2) solutions which are supposed to be used in this study

Design outcomes

Primary

Measure	Time frame
Safety	—

Secondary

Measure	Time frame
(Ocular Surface index score; OSDI), Value of Schirmer test, fluorescein score, rose bengal score, underlying disease, duration from hematopoietic stem cell transplantation, stem cell sources of hematopoietic stem cell transplantation	—

Countries

Japan

Contacts

Public Contactyoko ogawa

Keio University School of Medicine Department of Ophthalmology

yoko@z7.keio.jp+81353633972

Outcome results

None listed

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