A Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease (DED)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/21/2018 |
| Start Date: | July 9, 2018 |
| End Date: | April 2019 |
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)
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).
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).
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.
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.
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
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