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NCT01257607

A Phase 2, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 1% MIM-D3 and 5% MIM-D3 Ophthalmic Solutions in the Environment, and During Challenge in the Controlled Adverse Environmental (CAE) Model

Completed Phase 2 Last updated 15 August 2019
What this trial tests

Phase 2 trial testing MIM-D3 Ophthalmic Solution in Dry Eye in 150 participants. Completed in 1 May 2011.

Timeline
1 November 2010
Primary endpoint
1 May 2011
1 May 2011

Quick facts

Lead sponsorMimetogen Pharmaceuticals USA, Inc.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment150
Start date1 November 2010
Primary completion1 May 2011
Estimated completion1 May 2011
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mimetogen Pharmaceuticals USA, Inc. — full company profile →

Who can join

18 and older, any sex, with Dry Eye. 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.

Sponsor's own description

The objective of this study is to compare the safety and efficacy of 1% MIM-D3 and 5% MIM-D3 to placebo for the treatment of the signs and symptoms of dry eye.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Glaucoma 2.0: neuroprotection, neuroregeneration, neuroenhancement.
    Chang EE, Goldberg JL. · · 2012 · cited 254× · PMID 22349567 · DOI 10.1016/j.ophtha.2011.11.003
  2. Safety and efficacy of MIM-D3 ophthalmic solutions in a randomized, placebo-controlled Phase 2 clinical trial in patients with dry eye.
    Meerovitch K, Torkildsen G, Lonsdale J, Goldfarb H, et al · · 2013 · cited 45× · PMID 23836957 · DOI 10.2147/opth.s44688

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Other recruiting trials for Dry Eye

Currently open trials in the same condition.

Other Mimetogen Pharmaceuticals USA, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT01257607.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing