Allergic Conjunctivitis
Conditions
Brief summary
To purpose of this study is to establish the efficacy and safety of RX-10045 ophthalmic solution in alleviating the signs and symptoms of allergic conjunctivitis
Detailed description
Allergies are relatively common among the general population. Ocular signs and symptoms include itching, discomfort, redness, chemosis, tearing, and eyelid swelling. Allergic reactions can vary from a mild, self-limiting disease, to a debilitating condition that significantly impairs the quality of life of allergen-sensitive individuals. Currently approved treatments for ocular allergy reduce the signs and symptoms of the early phase reaction; however, evidence suggests that many patients suffer from the persistent late phase reaction. Manifestations of the late phase reaction occur 6 to 24 hours after allergen exposure and are characterized by an influx of acute inflammatory cells into the conjunctivae. Administration of anti-inflammatory agents decreases allergy signs and symptoms in both the early and late phase reactions. RX-10045 has been shown to be efficacious in multiple pre-clinical dry eye disease models and in a pre-clinical model of allergic conjunctivitis. The objective of this clinical study is to assess the safety and efficacy of RX-10045 ophthalmic solution for the treatment of the signs and symptoms of allergic conjunctivitis induced in the Conjunctival Allergen Challenge Model of allergic conjunctivitis at 15 minutes and 8 hours after medication instillation. It is anticipated that RX-10045 has therapeutic potential for the treatment of allergic conjunctivitis and an acceptable risk-benefit profile.
Interventions
DRUGRX-10045
RX-10045 Ophthalmic Solution, 0.09% At Visits 3A and 4, a trained study technician will instill one drop of the assigned, masked study treatment, into each eye.
DRUGVehicle for RX-10045 arm
Vehicle of RX-10045 Ophthalmic Solution At Visits 3A and 4, a trained study technician will instill one drop of the assigned, masked study treatment, into each eye.
Sponsors
C.T. Development America, 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
Subjects MUST: 1. Have a positive history of ocular allergies 2. Have a positive bilateral conjunctival allergen challenge (CAC) reaction
Exclusion criteria
Subjects MUST NOT: 1. Have known contraindications or sensitivities to study medication or its components 2. Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters 3. Use a disallowed medication during the period indicated prior to the enrollment or during the study 4. Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular itching | Baseline to day 14 | Ocular itching at defined timepoints up to 2 weeks |
| Conjunctival redness | Baseline to day 14 | Conjunctival redness evaluated by the investigator at defined timepoints up to 2 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ciliary and episcleral redness | Baseline to day 14 | Ciliary and episcleral redness evaluated by the investigator at defined timepoints up to 2 weeks |
| Chemosis | Baseline to day 14 | Chemosis evaluated by the investigator at defined timepoints up to 2 weeks |
| Eyelid swelling | Baseline to day 14 | Eyelid swelling evaluated by the subject at defined timepoints up to 2 weeks |
| Tearing | Baseline to day 14 | Tearing evaluated by the subject at defined timepoints up to 2 weeks |
Countries
United States
Outcome results
None listed