1% of Tramadol Ophthalmic Solution for Chronic Ocular Pain in Patients with Dry Eye: A prospective clinical study to examine the efficacy and safety

JRCT ID: jRCTs011210050

Registered date:17/11/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Chronic Ocular Pain with Dry Eye
• Date of first enrollment: 14/01/2022
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Unapproved route of administration of tramadol hydrochloride

Outcome(s)

• Primary Outcome: 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 Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Tagawa Yoshiaki
• Source(s) of Monetary Support: Rohto Pharmaceutical Co., Ltd.