A Phase 4 interventional study of TJO-018 (HA 0.15%) and Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add) in Dry Eye and Dry Eye Syndromes, sponsored by Taejoon Pharmaceutical Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-06-08.
Sponsored by Taejoon Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment
In patients with moderate to severe dry eye syndrome, the test drug (HA 0.15% eye drop) or the control drug (cyclosporin 0.05% eye drop) is administered for 12 weeks, and the corneal staining of each group would be evaluated. The study objective is to demonstrate that the test drug is not clinically inferior to the control drug.
Furthermore, the efficacy of combination therapy would be evaluated through exploratory combination therapy group.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 438 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Taejoon Pharmaceutical Co., Ltd. is the lead sponsor of 16 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HA 0.15% group was treated with HA 0.15% six times daily for 12 weeks
Drug: TJO-018 (HA 0.15%)
CsA 0.05% + CMC 0.5% group was treated with CsA 0.05% two times daily and CMC 0.5% two \~ six times daily for 12 weeks.
Drug: Cyclosporine Ophthalmic Emulsion 0.05% standard therapy (CMC 0.5% add)
HA 0.15% + CsA 0.05% group was treated with HA 0.15% six times daily and CsA 0.05% twice daily for 12 weeks.
Drug: TJO-018 (HA 0.15%) + Cyclosporine Ophthalmic Emulsion 0.05%
TJO-018 / one drop / 6 times daily in both eyes
Cyclosporine / one drop / twice daily in both eyes carboxymethylcellulose (CMC) / one drop / two\~six times daily in both eyes
TJO-018 (HA0.15%)/ one drop 6 times daily in both eyes Cyclosporine 0.05% /one drop twice daily in both eyes
Change From Baseline in Corneal Staining Score at Week 12
After 12 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change. * Scale: "Oxford grading system" that divides into six groups according to severity from 0 (absent) to 5 (severe). * The higher scores mean a worse outcome.
Time frame: Baseline and Week 12
Change From Baseline in Corneal Staining Score at Week 4 and Week 8
After 4, 8 weeks of administration of the drugs compare the therapeutic effectiveness between control drug and trial drug evaluated as the corneal staining score change. * Scale: "Oxford grading system" that divides into six groups according to severity from 0 (absent) to 5 (severe). * The higher scores mean a worse outcome.
Time frame: Baseline, Week 4 and Week 8
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Taejoon Pharmaceutical Co., Ltd.