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ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy

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ClinicalTrials.gov Identifier: NCT02332109
Recruitment Status : Completed
First Posted : January 6, 2015
Last Update Posted : June 7, 2016
Sponsor:
Information provided by (Responsible Party):
TRB Chemedica AG

Tracking Information
First Submitted Date December 19, 2014
First Posted Date January 6, 2015
Last Update Posted Date June 7, 2016
Study Start Date September 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 18, 2015)
Visual acuity (both eyes) [ Time Frame: Day 56 ]
Measurement of uncorrected and best corrected visual acuity (both eyes)
Original Primary Outcome Measures
 (submitted: January 2, 2015)
Corneal thickness [ Time Frame: Day 56 ]
Measurement of central corneal thickness (both eyes)
Change History Complete list of historical versions of study NCT02332109 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 18, 2015)
  • Corneal thickness [ Time Frame: Day 0, day 28 and day 56 ]
    Measurement of central corneal thickness (both eyes)
  • Visual acuity (both eyes) [ Time Frame: Day 0 and day 28 ]
    Measurement of uncorrected and best corrected visual acuity (both eyes)
  • Contrast perception (Measurement of contrast values (both eyes)) [ Time Frame: Day 0, day 28 and day 56 ]
    Measurement of contrast values (both eyes)
  • Subjective ocular complaints and symptoms (11-point Likert scale) [ Time Frame: Day 0, day 28 and day 56 ]
    The following ocular complaints or symptoms will be evaluated on an 11-point Likert scale ranging from '0' (no complaints) to '10' (maximum complaints):
    • glare sensitivity
    • burning
    • foreign body sensation
    • halos
    • pruritus
    • blurred vision
    • redness
    • pain
    • tingling
    • stitching
    • dryness
    • watering eyes
  • Safety parameter (Adverse events) [ Time Frame: Day 0, day 28 and day 56 ]
    Adverse events judged to be unexpected and (possibly) related to ODM 5 will be documented
Original Secondary Outcome Measures
 (submitted: January 2, 2015)
  • Corneal thickness [ Time Frame: Day 0 and day 14 ]
    Measurement of central corneal thickness (both eyes)
  • Ametropia (Measurement of uncorrected and best corrected visual acuity (both eyes)) [ Time Frame: Day 0, day 14 and day 56 ]
    Measurement of uncorrected and best corrected visual acuity (both eyes)
  • Contrast perception (Measurement of contrast values (both eyes)) [ Time Frame: Day 0, day 14 and day 56 ]
    Measurement of contrast values (both eyes)
  • Subjective ocular complaints and symptoms (11-point Likert scale) [ Time Frame: Day 0, day 14 and day 56 ]
    The following ocular complaints or symptoms will be evaluated on an 11-point Likert scale ranging from '0' (no complaints) to '10' (maximum complaints):
    • glare sensitivity
    • burning
    • foreign body sensation
    • halos
    • pruritus
    • blurred vision
    • redness
    • pain
    • tingling
    • stitching
    • dryness
    • watering eyes
  • Safety parameter (Adverse events) [ Time Frame: Day 0, day 14 and day 56 ]
    judged to be unexpected and (possibly) related to ODM 5 will be documented
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy
Official Title ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy
Brief Summary Clinical observation to confirm the clinical safety and efficacy of ODM 5 in the treatment of corneal edema caused by Fuchs' endothelial dystrophy.
Detailed Description Patients with a Fuchs' endothelial dystrophy-induced corneal edema and an ODM 5 therapy recommendation prior to their inclusion will be observed in normal practice setting in this post-market clinical follow-up study. In this indication, the use of ODM 5 should extract the fluid excess in the cornea away by an osmotic effect, enabling the cornea to temporarily regain a normal state of hydration. As a consequence, the patient's visual acuity, contrast perception, corneal thickness and ocular complaints/symptoms should improve. The hyaluronan in ODM 5 helps to protect and heal the cornea in case of irritation and thus, enables the cornea to regain a normal state of hydration and participates in improving the quality of vision.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with a Fuchs endothelial dystrophy-induced corneal edema and an ODM 5 therapy recommendation.
Condition
  • Fuchs' Endothelial Dystrophy
  • Corneal Edema
Intervention Device: ODM 5
ODM 5 is a CE-certified, preservative-free, hyperosmolar ophthalmological solution containing 5% sodium chloride and 0.15% sodium hyaluronate recommended for the reduction of corneal edema. The patient will use ODM 5 on a daily basis in accordance with the instructions for use and as recommended by the investigator over a period of 8 weeks.
Study Groups/Cohorts ODM 5-group
Intervention: Device: ODM 5
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 6, 2016)
29
Original Estimated Enrollment
 (submitted: January 2, 2015)
50
Actual Study Completion Date May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Presence of corneal oedema caused by Fuchs' endothelial dystrophy
  • Existing ODM 5 recommendation prior to inclusion

Exclusion Criteria:

  • Contact lens wear
  • Hypersensitivity to one of the ODM 5 components
  • Appointment for eye surgery within 8 weeks after date of inclusion
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02332109
Other Study ID Numbers ODM5FDE-PMCF-DE-2015-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party TRB Chemedica AG
Study Sponsor TRB Chemedica AG
Collaborators Not Provided
Investigators Not Provided
PRS Account TRB Chemedica AG
Verification Date June 2016