The prospective exploratory study of safety and efficacy on the patients post-penetrating keratoplasty of topical tacrolimus 0.1%.

The prospective exploratory study of safety and efficacy on the patients post-penetrating keratoplasty of topical tacrolimus 0.1%. - Inhibitory effect of topical tacrolimus 0.1% on the rejection of corneal graft.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000029669

Enrollment

Registered

2017-11-01

Start date

2017-11-01

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

Penetrating keratoplasty (PKP)

Interventions

Target drug: tacrolimus 0.1% ophthalmic susupension Control: artificial tear (My tear eye drop)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: "Patients with PKP who are relevant the following conditions 1) Patients with the history of PKP 2) Patients with the history of rejection 3) Patients with vascuralization in corneal stroma (more than half) 4) Atopic patients with karatoconus "

Exclusion criteria

Exclusion criteria: 1) Patients with allergic history against tavrolimus ophthalmic susupension 2) Patients with infectious eye disease 3) Patients with allergic history against betamethasone or fluorometholone ey drop 4) Diabetic patients with poor glycemic control 5) Glaucoma patients with poor IOP control 6) Patients with severe infectious disease 7) Patients with limbal transplantation 8) Patients with cancer, severe liver dysfunction, severe renal dysfunction, severe cardiac disease, and other severe conditions 9) Pregnant women, lactating women, may possibly be pregnant women 10) Patients whom the prior treatment with topical or systemic use of steroid or immunosuppressant within 4 week before initiation 11) Patients whom are expected to need a contraindicated durg use or therapy in the study period 12) Patients whom are considered unsuitable by doctor in charge

Design outcomes

Primary

Measure	Time frame
Rejection rates of the graft on week 52 post-operatively.	—

Secondary

Measure	Time frame
1) Survival rates of the graft on week 52 post-operatively "2) Survival rates of the graft on week 26, 52 and last observation post-operatively 3) Adverse drug reactions on week 26, 52 and last observation post-operatively 4) Best corrected visual acuity 5) Corneal endthelial cell density 6) Influenced factors to survival rate of the graft on week 52 post-operatively 7) Survival rates of the graft when adjustment of influence factors 8) Recruitment of dendritic cell and reconstitution of trigerminal"	—

Measure

Time frame

1) Survival rates of the graft on week 52 post-operatively "2) Survival rates of the graft on week 26, 52 and last observation post-operatively 3) Adverse drug reactions on week 26, 52 and last observation post-operatively 4) Best corrected visual acuity 5) Corneal endthelial cell density 6) Influenced factors to survival rate of the graft on week 52 post-operatively 7) Survival rates of the graft when adjustment of influence factors 8) Recruitment of dendritic cell and reconstitution of trigerminal"

—

Countries

Japan

Contacts

Public ContactJun Shimazaki

Tokyo Dental Collage Ichikawa General Hospital Ophthalmology

jun@eyebank.or.jp0473220151

Outcome results

None listed

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