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A Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease (DED)

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ClinicalTrials.gov Identifier: NCT03598699
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : January 13, 2021
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
AxeroVision, Inc.

Tracking Information
First Submitted Date  ICMJE July 16, 2018
First Posted Date  ICMJE July 26, 2018
Last Update Posted Date January 13, 2021
Actual Study Start Date  ICMJE July 9, 2018
Actual Primary Completion Date January 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Inferior corneal staining score [ Time Frame: Month 3 ]
    Change from Baseline in Ora Calibra® Corneal Staining Scale (0-"None" to 4-"Severe")
  • Eye dryness [ Time Frame: Month 3 ]
    Using the visual analogue scale (VAS) subjects will be asked to rate eye dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort. 0% corresponds to "no dryness" and 100% corresponds to "maximal dryness".
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Schirmer's test [ Time Frame: Month 3 ]
    Unanesthetized Schirmer's Test measures the length of the moistened area of a test strip in mm. Higher numbers indicate more tear production.
  • Total Ocular Surface and Disease Index (OSDI) © for Dry Eye [ Time Frame: Month 3 ]
    The OSDI is assessed on a scale from 0 to 100, where higher scores represent greater disability.
  • Tear film break-up time (TBUT) [ Time Frame: Month 3 ]
    The examiner will monitor the integrity of the tear film, noting the time it takes to form micelles from the time that the eye is opened. TFBUT will be measured in seconds using a stopwatch.
  • Conjunctival redness [ Time Frame: Month 3 ]
    Ora Calibra® Conjunctival Redness Scale for Dry Eye from 0-"None" to 4-"Severe".
  • Total lissamine green conjunctival staining [ Time Frame: Month 3 ]
    Oxford Grading Scale measures staining from 0-5 for each panel and 0-10 for the total exposed inter-palpebral conjunctiva. Higher numbers indicate more staining.
  • Ocular Discomfort Score [ Time Frame: Month 3 ]
    Ora Calibra® Ocular Discomfort Scale for Dry Eye from 0-"No Discomfort" to 4-"Constant Discomfort".
  • Symptom Assessment iN Dry Eye (SANDE) [ Time Frame: Month 3 ]
    Patients place a vertical line to indicate how often and how severe, on average, their eyes feel dry and/or irritated (0-"Rarely / Very Mild" to 100 mm "All the time / very severe").
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease (DED)
Official Title  ICMJE A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AXR-159 Ophthalmic Solution 3 mg/mL, 30 mg/mL, and 50 mg/mL in Patients With Dry Eye Disease (DED)
Brief Summary Protocol AXR201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 stages (Stage 1: AXR-159 Ophthalmic Solution (30 mg/mL or 50 mg/mL); Stage 2: AXR-159 Ophthalmic Solution (3 mg/mL, 30 mg/mL or 50 mg/mL) in approximately 430 patients diagnosed with dry eye disease (DED).
Detailed Description

Protocol AXR201701 is designed with 2 stages. For both Stages 1 and 2, patients with signs and symptoms of DED will be randomly assigned to receive either a single concentration of AXR-159 Ophthalmic Solution or AXR-159 Ophthalmic Solution Vehicle.

A screening visit will be followed by a baseline period where subjects will dose with AXR-159 Ophthalmic Solution Vehicle for 14 days. At the end of the baseline period patients who still exhibit signs and symptoms of DED will be enrolled into a 3-month bouble-masked treatment period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye
Intervention  ICMJE Drug: AXR-159
AXR-159 Ophthalmic Solution
Study Arms  ICMJE
  • Experimental: AXR-159 Ophthalmic Solution 3 mg/mL
    AXR-159 Low Dose
    Intervention: Drug: AXR-159
  • Experimental: AXR-159 Ophthalmic Solution 30 mg/mL
    AXR-159 Mid Dose
    Intervention: Drug: AXR-159
  • Experimental: AXR-159 Ophthalmic Solution 50 mg/mL
    AXR-159 High Dose
    Intervention: Drug: AXR-159
  • Placebo Comparator: AXR-159 Ophthalmic Solution Vehicle
    Control Group
    Intervention: Drug: AXR-159
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2018)
102
Original Estimated Enrollment  ICMJE
 (submitted: July 23, 2018)
430
Actual Study Completion Date  ICMJE January 12, 2021
Actual Primary Completion Date January 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female, 18 years of age or older at screening visit
  • Best-corrected visual acuity (BCVA) of 20/100 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye
  • Reported history of dry eye for at least 6 months
  • Corneal fluorescein staining score ≥ 2
  • Eye dryness score ≥ 40
  • Total Ocular Surface Disease Index (OSDI) score > 18

Exclusion Criteria:

  • Uncontrolled ocular disease (except for dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease
  • Patient has glaucoma, ocular hypertension, on IOP-lowering medications or have previously undergone any glaucoma laser or surgical procedure.
  • Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or compromised corneal integrity
  • BCVA worse than 20/100 in either eye
  • Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye
  • Keratoconjunctivitis sicca secondary to destruction of conjunctival goblet cells
  • Patients with clinically significant inflammation of the lid margin such as anterior blepharitis or ocular rosacea
  • Recent (within the past 3 months) ocular surgery, trauma or herpes
  • Use of contact lenses in either eye within one month prior to the screening visit or anticipated use during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03598699
Other Study ID Numbers  ICMJE AXR201701
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AxeroVision, Inc.
Study Sponsor  ICMJE AxeroVision, Inc.
Collaborators  ICMJE ORA, Inc.
Investigators  ICMJE
Principal Investigator: Gail L Torkildson, MD Andover Eye Associates; 138 Haverhill Street; Andover MA 01810
PRS Account AxeroVision, Inc.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP