Proof of concept trial of ibudilast ophthalmic solution for accommodative asthenopia.

Proof of concept trial of ibudilast ophthalmic solution for accommodative asthenopia. - Proof of concept trial of ibudilast ophthalmic solution for accommodative asthenopia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014695

Enrollment

Registered

2014-07-30

Start date

2014-08-12

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

Accommodative asthenopia

Interventions

0.01% ibudilas ophthalmic solution :Apply 1 drop at a time, 4 times daily, for 4 weeks 0.02% cyanocobalamin ophthalmic solution: Apply 1 drop at a time, 4 times daily, for 4 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) The patients who consent to participate in this study by informed concent 2)The patient over 20 and under40 years of age 3) Outpatient 4) The patients who do not require a frequent change of glasses or contact lenses during the study period and corrected visual acuity above 0.8 and refraction below -3.0D. 5) Patients with symptoms of asthenopia, and frequent high-frequency components in the vicinity of resting state of accommodation in accomodative microfluctuation of objective remark

Exclusion criteria

Exclusion criteria: 1) Patients with a history of allergy to experimental drug 2) Astigmatism patients over -2.0D 3) Patients with punctal plug as a treatment for dry eye 4) Patients with ocular deviation , ocular inflammation not including dry eye (including ocular allergy) , ocular infection, glaucoma or diabetes that affect the efficacy evaluation 5) Patients with corneal epithelium disorder over moderate 6) Patients who underwent cataract surgery or refractive surgery 7) Patients who underwent ophthalmic surgery within 3 months 8)Patients using eye drops except the dry eye syndrome therapeutic drug. 9) Patients with abnormalities evident on the refractive response, such as presbyopia, etc. 10) Patients with systemic disease that may affect the safety or effectiveness of the drug evaluation

Design outcomes

Primary

Measure	Time frame
Changes in the frequency of occurrence of HFC in accommodative microfluctuation	—

Secondary

Measure	Time frame
Subjective symptoms (questionnaire NRS) Degree of refraction, Vision Regulation Accommodative response Effect on tear secretion	—

Countries

Japan

Contacts

Public ContactTomonaga Takase

Nippon Medical School Hospital IRB

clinicaltrial@nms.ac.jp03-3822-2131

Outcome results

None listed

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