A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)

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Brief Title

A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)

Official Title

A Phase IIa, Randomized, Double-Masked, Placebo-Controlled, Parallel-Group, Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD) - PHANTOM Study

Brief Summary

      This is a Phase IIa study to assess efficacy and safety of STN1010904 ophthalmic suspension
      (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with
      Fuchs Endothelial Corneal Dystrophy (FECD). This study will consist of a Screening Period of
      up to 15 days and an 18-month Double-Masked Treatment Period.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Change from baseline in best corrected visual acuity (BCVA) with contrast level of 100% at Month 18

Secondary Outcome

 Best corrected visual acuity (BCVA) with contrast level of 100% at all post-baseline visits

Condition

Fuchs Endothelial Corneal Dystrophy

Intervention

STN1010904 ophthalmic suspension 0.03% BID

Study Arms / Comparison Groups

 STN1010904 ophthalmic suspension 0.03% BID
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

80

Start Date

May 19, 2022

Completion Date

March 2025

Primary Completion Date

March 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female diagnosed with FECD.

        Exclusion Criteria:

          -  Females who are pregnant or lactating.

          -  Any ocular surgery for FECD (e.g., penetrating keratoplasty (PKP), Descemet stripping
             endothelial keratoplasty (DSEK), Descemet membrane endothelial keratoplasty (DMEK),
             Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet stripping only
             (DSO) in the study eye.
      

Gender

All

Ages

30 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

, +1 415-268-9100, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05376176

Organization ID

101090401IN


Responsible Party

Sponsor

Study Sponsor

Santen Inc.

Collaborators

 ActualEyes Inc.

Study Sponsor

, , 


Verification Date

June 2022