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NCT02665234
A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye Disease
Phase 3 trial testing 1% Tavilermide Ophthalmic Solution in Keratoconjunctivitis Sicca in 400 participants. Completed in 1 March 2017.
1 February 2017
Quick facts
| Lead sponsor | Mimetogen Pharmaceuticals USA, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 400 |
| Start date | 1 January 2016 |
| Primary completion | 1 February 2017 |
| Estimated completion | 1 March 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- 1% Tavilermide Ophthalmic Solution — full drug profile →
- Placebo Ophthalmic Solution — full drug profile →
Conditions studied
- Keratoconjunctivitis Sicca — all drugs for Keratoconjunctivitis Sicca →
Sponsor
Mimetogen Pharmaceuticals USA, Inc. — full company profile →
Who can join
18 and older, any sex, with Keratoconjunctivitis Sicca. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Total Corneal Fluorescein Staining Using The Ora Calibra Scale
Time frame: Day 57
An assessment of the total corneal fluorescein staining using the Ora Calibra Scale both immediately prior to and immediately following exposure to a challenge in a controlled adverse environment (CAE) -
Ocular Discomfort Using The Ora Calibra Scale
Time frame: Day 57
A patient-reported subjective assessment of ocular discomfort recorded at each of the 5 office visits throughout the treatment period
Sponsor's own description
The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye disease.
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 NCT02665234
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Mimetogen Pharmaceuticals USA, Inc. trials
Trials by the same sponsor.
- NCT05848128 — Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye · Phase 3 · completed
- NCT03925727 — Tavilermide Ophthalmic Solution for the Treatment of Dry Eye · 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 NCT02665234 (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 Mimetogen Pharmaceuticals USA, Inc.
- Last refreshed: 13 August 2019
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/NCT02665234.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing