Clinical trial NCT01639846: Evaluation of the Onset and Duration of Action of RX-10045 in Allergic Conjunctivitis
Official title: A Single-Center, Double-Masked, Randomized, Vehicle Controlled Evaluation of the Onset and Duration of Action of RX-10045 Ophthalmic Solution, 0.09% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC) Model of Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: C.T. Development America, Inc.
Sponsor class: INDUSTRY
First posted: 2012-07-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ocular itching
timeFrame: Baseline to day 14
measure: Conjunctival redness
timeFrame: Baseline to day 14
Secondary outcomes:
measure: Ciliary and episcleral redness
timeFrame: Baseline to day 14
measure: Chemosis
timeFrame: Baseline to day 14
measure: Eyelid swelling
timeFrame: Baseline to day 14
measure: Tearing
timeFrame: Baseline to day 14
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: Andover Eye Associates
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References: