Evaluation of the Onset and Duration of Action of RX-10045 in Allergic Conjunctivitis

C.T. Development America

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: Vehicle for RX-10045 arm; Drug: RX-10045

Study type: Interventional

Funder types: Industry

Identifiers

NCT01639846

CTD1202

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

RX-10045 active arm

Experimental group

Description:

RX-10045 Ophthalmic Solution, 0.09%

Treatment:

Drug: RX-10045

Vehicle for RX-10045 arm

Placebo Comparator group

Description:

Vehicle of RX-10045 Ophthalmic Solution

Treatment:

Drug: Vehicle for RX-10045 arm