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NCT01363713
A Long-term Open-label Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis - Phase 3 -
Phase 3 trial testing DE-114 ophthalmic solution in Allergic Conjunctivitis in 130 participants. Completed.
Quick facts
| Lead sponsor | Santen Pharmaceutical Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Enrollment | 130 |
| Primary completion | 1 September 2012 |
| Sites | 1 location across Japan |
Drugs / interventions tested
- DE-114 ophthalmic solution — full drug profile →
Conditions studied
- Allergic Conjunctivitis — all drugs for Allergic Conjunctivitis →
Sponsor
Santen Pharmaceutical Co., Ltd. — full company profile →
Who can join
12 and older, any sex, with Allergic Conjunctivitis.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change in Ocular Itching Score by Visit
Time frame: From baseline to 8-week
Change from baseline in the average of Ocular itching score over the past 3 days. Ocular itching was assessed by the subject and graded on a 5 points scale of 0-4 (0=no itching, 4=incapacitating itch). The main purpose of this study is not to confirm but to evaluate safety of long term use of this drug, so primary variable was not defined.
Sponsor's own description
Safety and efficacy of DE-114 ophthalmic solution will be evaluated in patients with allergic conjunctivitis, in an open-label, multicenter study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01363713
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Allergic Conjunctivitis
Currently open trials in the same condition.
- NCT07309432 — Study of Bet v1 Antibodies Effect on Eye Allergy Symptoms in Adolescents and Adults With Birch Pollen Allergy · Phase 3 · recruiting
- NCT06686472 — Evaluation of TL-925 for the Treatment of Allergic Conjunctivitis · Phase 2 · recruiting
Other Santen Pharmaceutical Co., Ltd. trials
Trials by the same sponsor.
- NCT06911216 — A Pharmacokinetics (PK) Study in Healthy Adults · EARLY_PHASE1 · completed
- NCT06666855 — A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China · Phase 3 · active not recruiting
- NCT05905653 — Pharmacokinetic Study of STN1012600 Ophthalmic Solution in Healthy Adult Males Volunteers · Phase 1 · completed
- NCT05495061 — A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension · Phase 3 · completed
- NCT05503901 — A Long Term Study of STN1012600 in Subjects With Open Angle Glaucoma or Ocular Hypertension · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01363713 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Santen Pharmaceutical Co., Ltd.
- Last refreshed: 25 September 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01363713.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing