Evaluation of the Onset and Duration of Action of RX-10045 in Allergic Conjunctivitis
- Conditions
- Allergic Conjunctivitis
- Interventions
- Drug: Vehicle for RX-10045 arm
- Registration Number
- NCT01639846
- Lead Sponsor
- C.T. Development America, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Subjects MUST:
- Have a positive history of ocular allergies
- Have a positive bilateral conjunctival allergen challenge (CAC) reaction
Subjects MUST NOT:
- Have known contraindications or sensitivities to study medication or its components
- Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
- Use a disallowed medication during the period indicated prior to the enrollment or during the study
- Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RX-10045 active arm RX-10045 RX-10045 Ophthalmic Solution, 0.09% Vehicle for RX-10045 arm Vehicle for RX-10045 arm Vehicle of RX-10045 Ophthalmic Solution
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States