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

NCT ID: NCT01639846

Last Updated: 2013-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2012-08-31

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.

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

RX-10045 active arm

RX-10045 Ophthalmic Solution, 0.09%

Group Type: EXPERIMENTAL

RX-10045

Intervention Type: DRUG

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.

Vehicle for RX-10045 arm

Vehicle of RX-10045 Ophthalmic Solution

Group Type: PLACEBO_COMPARATOR

Vehicle for RX-10045 arm

Intervention Type: DRUG

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.

Interventions

RX-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.

Intervention Type: DRUG

Vehicle 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.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C.T. Development America, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail Torkildsen, MD

Role: PRINCIPAL_INVESTIGATOR

Andover Eye Associates

Locations

Andover Eye Associates

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

CTD1202

Identifier Type: -

Identifier Source: org_study_id