A Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease (DED)
Study Details
Study Description
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 |
|---|---|---|
| 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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Inferior corneal staining score [Month 3]
Change from Baseline in Ora Calibra® Corneal Staining Scale (0-"None" to 4-"Severe")
- Eye dryness [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
- Schirmer's test [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 [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) [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 [Month 3]
Ora Calibra® Conjunctival Redness Scale for Dry Eye from 0-"None" to 4-"Severe".
- Total lissamine green conjunctival staining [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 [Month 3]
Ora Calibra® Ocular Discomfort Scale for Dry Eye from 0-"No Discomfort" to 4-"Constant Discomfort".
- Symptom Assessment iN Dry Eye (SANDE) [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").
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Andover Eye Associates | Andover | Massachusetts | United States | 01810 |
| 2 | Andover Eye Associates | Raynham | Massachusetts | United States | 02767 |
| 3 | Total Eye Care, P.A. | Memphis | Tennessee | United States | 38119 |
Sponsors and Collaborators
- AxeroVision, Inc.
- ORA, Inc.
Investigators
- Principal Investigator: Gail L Torkildson, MD, Andover Eye Associates; 138 Haverhill Street; Andover MA 01810
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AXR201701