Accommodative asthenopia
Conditions
Interventions
investigational material(s)
Generic name etc : KRP-KC318E
INN of investigational material : -
Therapeutic category code : 131 Agents for ophthalmic use
Dosage and Administration for Investigational ma
Sponsors
Senju Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with accommodative asthenopia 2) Japanese living in Japan 3) Patients with subjective symptoms related to accommodative asthenopia 4) Written informed consent obtained after adequate explanation on participating the study 5) Patients with 0.5 or more best corrected visual acuity etc.
Exclusion criteria
Exclusion criteria: 1) Patients requiring change the degree of glasses during the study period 2) Patients with history of ocular or refractive surgery 3) Patients who have received intravitreal, sub-Tenon or subconjunctival administration 4) Patients who have received administration of corticosteroid agent 5) Patients with accommodative disorder of the eye 6) Patients with ophthalmic disease except for correctable refractive error 7) Patients who have or may develop any allergic symptoms during the study 8) Patients with history of corneal transplantation 9) Patients with a cancer, a serious systemic disease or a neuropsychiatric disease 10) Patients with history of allergy or significant adverse drug reaction to any ingredients of drugs used in this study 11) Patients who are pregnant, breastfeeding, potentially pregnant or who desire to be pregnant from consent to the end of the treatment period 12) Patients unwilling to consent to contraception etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Changes in high frequency component (HFC) at week 4 from the baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy Changes in HFC, adverse events, etc. | — |
Countries
Japan
Outcome results
None listed