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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03598699
Recruitment Status : Active, not recruiting
First Posted : July 25, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
AxeroVision, Inc.

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).

Condition or disease Intervention/treatment Phase
Dry Eye Drug: AXR-159 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : July 9, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arm Intervention/treatment
Experimental: AXR-159 Ophthalmic Solution 3 mg/mL
AXR-159 Low Dose
Drug: AXR-159
AXR-159 Ophthalmic Solution

Experimental: AXR-159 Ophthalmic Solution 30 mg/mL
AXR-159 Mid Dose
Drug: AXR-159
AXR-159 Ophthalmic Solution

Experimental: AXR-159 Ophthalmic Solution 50 mg/mL
AXR-159 High Dose
Drug: AXR-159
AXR-159 Ophthalmic Solution

Placebo Comparator: AXR-159 Ophthalmic Solution Vehicle
Control Group
Drug: AXR-159
AXR-159 Ophthalmic Solution




Primary Outcome Measures :
  1. Inferior corneal staining score [ Time Frame: Month 3 ]
    Change from Baseline in Ora Calibra® Corneal Staining Scale (0-"None" to 4-"Severe")

  2. 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".


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Conjunctival redness [ Time Frame: Month 3 ]
    Ora Calibra® Conjunctival Redness Scale for Dry Eye from 0-"None" to 4-"Severe".

  5. 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.

  6. Ocular Discomfort Score [ Time Frame: Month 3 ]
    Ora Calibra® Ocular Discomfort Scale for Dry Eye from 0-"No Discomfort" to 4-"Constant Discomfort".

  7. 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").



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598699


Locations
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United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Andover Eye Associates
Raynham, Massachusetts, United States, 02767
United States, Tennessee
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119
Sponsors and Collaborators
AxeroVision, Inc.
ORA, Inc.
Investigators
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Principal Investigator: Gail L Torkildson, MD Andover Eye Associates; 138 Haverhill Street; Andover MA 01810

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Responsible Party: AxeroVision, Inc.
ClinicalTrials.gov Identifier: NCT03598699     History of Changes
Other Study ID Numbers: AXR201701
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Ophthalmic Solutions
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Pharmaceutical Solutions