A Study to Evaluate AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease

NCT03598699 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AXR201701
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 3

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).

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Inferior Corneal Staining Score

  Change from Baseline in Ora Calibra® Corneal and Conjunctival Staining Scale with a range from 0 to 4 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe) in the study eye. Higher negative scores mean a better outcome.

  Month 3

• Eye Dryness

  Change from baseline in Eye Dryness score on a subject level across both eyes. Using the visual analogue scale (VAS) subjects rated eye dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort with a range of 0 to 100. 0% corresponds to "no dryness" (no discomfort) and 100% corresponds to "maximal dryness" indicating maximal discomfort. A greater negative change from baseline score means a better outcome.

  Month 3

Secondary Outcomes (5)

• Total Ocular Surface and Disease Index (OSDI) © for Dry Eye

  Month 3

• Schirmer's Test

  Month 3

• Tear Film Break-up Time (TBUT)

  Month 3

• Conjunctival Redness Score

  Month 3

• Total Lissamine Green Conjunctival Staining

  Month 3

Study Arms (4)

AXR-159 Ophthalmic Solution 3 mg/mL

EXPERIMENTAL

AXR-159 Low Dose

Drug: AXR-159

AXR-159 Ophthalmic Solution 30 mg/mL

EXPERIMENTAL

AXR-159 Mid Dose

Drug: AXR-159

AXR-159 Ophthalmic Solution 50 mg/mL

EXPERIMENTAL

AXR-159 High Dose

Drug: AXR-159

AXR-159 Ophthalmic Solution Vehicle

PLACEBO COMPARATOR

Control Group

Drug: Vehicle

Interventions

AXR-159 DRUG

AXR-159 Ophthalmic Solution

AXR-159 Ophthalmic Solution 3 mg/mL; AXR-159 Ophthalmic Solution 30 mg/mL; AXR-159 Ophthalmic Solution 50 mg/mL

Vehicle DRUG

AXR-159 Ophthalmic Solution Vehicle

AXR-159 Ophthalmic Solution Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AxeroVision, Inc.: lead
• ORA, Inc.: collaborator

Study Sites (3)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Andover Eye Associates

Raynham, Massachusetts, 02767, United States

Location

Total Eye Care, P.A.

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Limitations and Caveats

The study was planned as a 2-stage study but has been terminated after completion of Stage 1 due to lack of funding.

Results Point of Contact

• Title: Dr. Achim Krauss
• Organization: AxeroVision, Inc.

achim.h.krauss@gmail.com

+1 (484) 238-6255

Study Officials

• Gail L Torkildson, MD

  Andover Eye Associates, 138 Haverhill Street, Andover MA 01810

  PRINCIPAL INVESTIGATOR

• Kenneth R Kenyon, MD

  Andover Eye Associates, 675 Paramount Drive, Raynham, MA 02767

  PRINCIPAL INVESTIGATOR

• Eugene McLaurin, MD

  Total Eye Care, P.A., 6060 Primacy Parkway, Memphis, TN 38119

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2018
• First Posted: July 26, 2018
• Study Start: June 26, 2018
• Primary Completion: December 28, 2018
• Study Completion: January 9, 2019
• Last Updated: October 13, 2023
• Results First Posted: October 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)