Chronic Ocular Pain with Dry Eye
Conditions
Interventions
Unapproved route of administration of tramadol hydrochloride
Sponsors
Tagawa Yoshiaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patient aged 20 years or older on the date of informed consent 2)Patient with chronic ocular pain with dry eye for 3 months or over on the date of informed consent 3)Patient willing to participate in the clinical study with a fair understanding of the study content and when the informed consent is filled by the patient
Exclusion criteria
Exclusion criteria: 1)Patient with severe hepatic disorder, renal disorder, vascular disorder, pulmonary disease, endocrine disease (includes diabetes mellitus) , mental illness (includes depression and anxiety disorder) 2)Patient with corneal erosion on the ocular surface, and corneal ulcer 3) Patient whose principal/sub investigator judged inappropriate for a study subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS score of ocular pain and its change rate between the baseline(Visit1) and 28 days(Visit5) after the repeated-administration of the target drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) VAS score of ocular pain and its change rate between the baseline(Visit1) and 14 days(Visit4) after the repeated-administration of the target drug. 2) Change of VAS score between the baseline(Visit1) and 14 days(Visit4), and 28 days(Visit5) after the repeated-administration of the target drug. 3) Proportion of cases that improved over 30% and 50% in VAS score between the baseline(Visit1) and 14 days(Visit4), and 28 days(Visit5) after the repeated-administration of the target drug. 4) NRS score of ocular pain, its change, and transition between the baseline (Visit1) and 28 days after the repeated-administration of the target drug 5) The scores of items below, their changes, and transitions between the baseline (Visit1) and 14 days and 28 days after the repeated-administration of the target drug a) BUT, Schirmer's test b) Fluorescein staining score c) DEQS, SF-MPQ2 6) Analgesic effect a) Time till the effect be observed and its transition b) Retention time and its transition 7) Functional MRI study of the brain region that regulates pain 8) Observation of corneal sensory nerve and inflammatory cells using confocal laser scanning microscope | — |
Contacts
Public ContactYoshiaki Tagawa
Hokkaido University Hospital
Outcome results
None listed