Clinical trial NCT03598699: A Study to Evaluate AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye
Lead sponsor: AxeroVision, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2018-07-26
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 double-masked treatment period.

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

Primary outcomes:
measure: Inferior Corneal Staining Score
timeFrame: Month 3
measure: Eye Dryness
timeFrame: Month 3
Secondary outcomes:
measure: Total Ocular Surface and Disease Index (OSDI) © for Dry Eye
timeFrame: Month 3
measure: Schirmer's Test
timeFrame: Month 3
measure: Tear Film Break-up Time (TBUT)
timeFrame: Month 3
measure: Conjunctival Redness Score
timeFrame: Month 3
measure: Total Lissamine Green Conjunctival Staining
timeFrame: Month 3
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Raynham
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Memphis
country: United States
facility: Total Eye Care, P.A.
state: Tennessee
Study officials:
affiliation: Andover Eye Associates, 138 Haverhill Street, Andover MA 01810
name: Gail L Torkildson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Andover Eye Associates, 675 Paramount Drive, Raynham, MA 02767
name: Kenneth R Kenyon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Total Eye Care, P.A., 6060 Primacy Parkway, Memphis, TN 38119
name: Eugene McLaurin, MD
role: PRINCIPAL_INVESTIGATOR
References: