Phase 2
N=102
A Study to Evaluate AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT03598699 ↗Enrolled (actual)
102
Serious AEs
1.0%
Results posted
Oct 2023
Primary outcome: Primary: Inferior Corneal Staining Score — -0.08; -0.03 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AXR-159 (Drug); Vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AxeroVision, Inc.
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inferior Corneal Staining Score |
-0.08; -0.03 | — |
| PRIMARY Eye Dryness |
-12.5; -14.9 | — |
| SECONDARY Total Ocular Surface and Disease Index (OSDI) © for Dry Eye |
-8.8; -5.0 | — |
| SECONDARY Schirmer's Test |
0.8; 1.9 | — |
| SECONDARY Tear Film Break-up Time (TBUT) |
-0.143; -0.178 | — |
| SECONDARY Conjunctival Redness Score |
0.04; 0.26 | — |
| SECONDARY Total Lissamine Green Conjunctival Staining |
0.40; 0.59 | — |
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).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03598699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.