Dry Eye Disease
Conditions
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.
Interventions
PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.
DRUGPlacebo Ophthalmic Solution
Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.
Sponsors
Palatin Technologies, Inc
ORA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed