Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye
- Conditions
- Dry Eye Disease
- Interventions
- Drug: Placebo Ophthalmic SolutionDrug: PL9643 Ophthalmic Solution
- Registration Number
- NCT04268069
- Lead Sponsor
- ORA, Inc.
- Brief Summary
Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.
- Detailed Description
The clinical trial is a Phase 2, multi center, randomized, double masked and placebo controlled study.
During a 14-day study run-in period (for the purpose of subject selection) prior to randomization, all subjects will receive Placebo Ophthalmic Solution (vehicle) bilaterally. During the screening period, exposure to the CAE® will be conducted to ascertain eligibility to enter the study at Visit 1 and Visit 2. Those who qualify at Visit 2 will be randomized to receive study drug in a double-masked fashion for 12 weeks. The CAE® exposure will occur at all Visits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- Be at least 18 years of age.
- Provided written informed consent.
- Have a reported history of dry eye
- Have a history of use or desire to use eye drops for dry eye symptoms
- Have corrected visual acuity greater than or equal to +0.7 in both eyes
- Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal)
- Have any planned ocular and/or lid surgeries over the study period.
- Have an uncontrolled systemic disease.
- Be a woman who is pregnant, nursing or planning a pregnancy.
- Be a woman of childbearing potential who is not using an acceptable means of birth control
- Have a known allergy and/or sensitivity to the test article or its components.
- Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
- Have used an investigational drug or device within 30 days of Visit 1
- Be unable or unwilling to follow instructions, including participation in all study assessments and visits
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Ophthalmic Solution (vehicle) Placebo Ophthalmic Solution vehicle PL9643 Ophthalmic Solution PL9643 Ophthalmic Solution PL9643 Ophthalmic Solution
- Primary Outcome Measures
Name Time Method Inferior Corneal Fluorescein Staining Using The Ora Calibra Scale Day 85 An assessment of corneal fluorescein staining using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Ocular Discomfort Using The Ora Calibra Scale Day 85 A patient-reported subjective assessment of ocular discomfort using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale recorded at each study visit throughout the treatment period
- Secondary Outcome Measures
Name Time Method Conjunctival Lissamine Green Staining Using The Ora Calibra Scale 12 weeks An assessment of conjunctival lissamine green staining using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Conjunctival Redness Using The Ora Calibra Scale 12 weeks An assessment of conjunctival redness using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Corneal Fluorescein Staining Using The Ora Calibra Scale 12 weeks An assessment of corneal fluorescein staining using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Trial Locations
- Locations (3)
Total Eye Care, P.A.
🇺🇸Memphis, Tennessee, United States
Andover Eye Associates
🇺🇸Raynham, Massachusetts, United States
Vita Eye Clinc
🇺🇸Shelby, North Carolina, United States