OPH clinical study

Phase 2

• Conditions: Dry eye

• Registration Number: JPRN-jRCT2080222972
• Lead Sponsor: Ophtecs Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-28
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Outpatient 20 years of age or older.
Outpatients who have been given a definite diagnosis of dry eye according to the Diagnostic Criteria by the Dry Eye Society (1995) .

Exclusion Criteria

Patients with Stevens-Johnson syndrome or ocular pemphigoid
Patients with keratoconjunctival chemical or thermal injury
Patients with any ocular surface disease other than dry eye (e.g. allergic conjunctivitis) requiring treatment
Any anatomical and functional eyelid abnormality (e.g. insufficient eyelid closure)
History of an allogeneic hematopoietic stem cell transplantation
History of intraocular surgery (including laser therapy) within 3 months prior to informed consent
History of a punctal plug surgery and/or punctal closing surgery (excluding no history of the surgeries in the study eye, loss of punctal plug or puncta opening at the time of informed consent)
Patients who will/must use any eye drops for dry eye treatment other than the study drug, ophthalmic drug, prohibited concomitant drug or therapy during the study period
Patients who are pregnant or breastfeeding, have a possibility of pregnancy or are willing to pregnant during the study period
Patients who need to wear contact lenses
Patients who had participated any other trial within the past 4 months

Study & Design

• Study Type: Interventional
• Study Design: Not specified