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NCT01960010
A Phase 3, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1% MIM-D3 Ophthalmic Solution in the Environment, and During Challenge in the Controlled Adverse Environmental (CAE) Model for the Treatment of Dry Eye
Phase 3 trial testing MIM-D3 Ophthalmic Solution in Dry Eye Syndromes in 403 participants. Completed in 1 August 2014.
1 August 2014
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 | 403 |
| Start date | 1 October 2013 |
| Primary completion | 1 August 2014 |
| Estimated completion | 1 August 2014 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- MIM-D3 Ophthalmic Solution — full drug profile →
- Vehicle
Conditions studied
- Dry Eye Syndromes — all drugs for Dry Eye Syndromes →
Sponsor
Mimetogen Pharmaceuticals USA, Inc. — full company profile →
Who can join
18 and older, any sex, with Dry Eye Syndromes. 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.
-
Corneal Fluorescein Staining
Time frame: Day 29 -
Ocular Dryness
Time frame: 28 Days
Patient-derived, daily dryness symptoms for the 28 day time period will be be averaged to obtain a dryness score for the entire 28-day period. Average dryness scores over the 28-day treatment period will be compared between 1% MIM-D3 and placebo using t-tests.
Sponsor's own description
The purpose of this study is to assess the safety and efficacy of MIM-D3 Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye.
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 NCT01960010
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Dry Eye Syndromes
Currently open trials in the same condition.
- NCT07412860 — Clinical Investigation Between the Topical Administration of a Tear Substitute With Ancillary Medicinal Substance and Hy · NA · recruiting
- NCT06913504 — Comparison Of Blue Light Filter Feature and Blue Blocking Lenses in Digital Device Users With Dry Eye Patients · NA · active not recruiting
- NCT06913465 — The Impact of Hypothyroidism on Tear Production and Dry Eye Symptoms: Implications for Optometric Care · active not recruiting
- NCT06831253 — Efficacy of Platelet-Rich Plasma Injection in Dry Eye Syndrome · NA · recruiting
- NCT06220474 — Therapeutic Efficacy and Safety of Non-Invasive RF Treatment in Refractory MGD · NA · recruiting
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 NCT01960010 (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: 15 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/NCT01960010.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing