Effect of the dual treatment of diquafosol sodium and rebamipide on dry eye syndrome related to chronic graft versus host disease and Sjogrens syndrome

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000013234
• Date of registration: 01/04/2014
• Prospective Registration: Yes
• Primary sponsor: Keio University School of Medicine
• Public title: Effect of the dual treatment of diquafosol sodium and rebamipide on dry eye syndrome related to chronic graft versus host disease and Sjogrens syndrome
• Scientific title: Effect of the dual treatment of diquafosol sodium and rebamipide on dry eye syndrome related to chronic graft versus host disease and Sjogrens syndrome - Effect of diquafosol sodium and rebamipide on GVHD and Sjogrens syndrome related dry eye.
• Date of first enrolment: 2014/04/01
• Target sample size: 20
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015442
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not applicable

Countries of recruitment

Japan

Contacts

• Name: Yoko Ogawa
• Affiliation: Keio University School of Medicine Department of ophthalmology

• Name: Yoko Ogawa
• Affiliation: Keio University School of Medicine Department of Ophthalmology

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: 1, Dry eye syndrome severity level 4 (dry eye workshop classification 2007) 2, Patients dosed diquafosol sodium and / or rebamipide ophthalmic solution 3, Patients having a concern of becoming severe dry eye because of having GVHD in other organs and so on 4, Patients with ocular pemphigoid, and Stevens-Johnson syndrome 5, Patients with a history of ophthalmic surgery within 6 months before the study 6, Patients wearing contact lens 7, Patients who will be applied radiation treatment during the study 8, Patients dosed cevimeline hydrochloride hydrate and /or pilocarpine(eye drop or oral drug) 9, Patients who will be ineligible for registration the study

Age minimum: 20years-old
Age maximum: 75years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Dry eye related to chronic GVHD and Sjogren s syndrome

Intervention(s)

Diquafosol sodium and rebamipide ophthalmic solution
Artifical tears, vitamin A ophthalmic solution, or/and sodium hyaluronate ophthalmic solution

Primary Outcome(s)

Anterior ocular segment remark Corneal sensitivity Schirmer test Tear film breakup time Fluorescein staining Rose bengal staining Subjective symptom

Source(s) of Monetary Support

Keio University

Ethics review

Status: YES
Approval date:
Contact:

Results

• Results available: Yes
• Date Completed: 31/03/2018