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

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

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

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: RX-10045; Drug: Vehicle for RX-10045 arm

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RX-10045 active arm; RX-10045 Ophthalmic Solution, 0.09%	Drug: 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.
Placebo Comparator: Vehicle for RX-10045 arm; Vehicle of RX-10045 Ophthalmic Solution	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ocular itching	Ocular itching at defined timepoints up to 2 weeks	Baseline to day 14
Conjunctival redness	Conjunctival redness evaluated by the investigator at defined timepoints up to 2 weeks	Baseline to day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ciliary and episcleral redness	Ciliary and episcleral redness evaluated by the investigator at defined timepoints up to 2 weeks	Baseline to day 14
Chemosis	Chemosis evaluated by the investigator at defined timepoints up to 2 weeks	Baseline to day 14
Eyelid swelling	Eyelid swelling evaluated by the subject at defined timepoints up to 2 weeks	Baseline to day 14
Tearing	Tearing evaluated by the subject at defined timepoints up to 2 weeks	Baseline to day 14

Collaborators and Investigators

• Sponsor: C.T. Development America, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: July 11, 2012
• First Submitted That Met QC Criteria: July 12, 2012
• First Posted (Estimate): July 13, 2012

Study Record Updates

• Last Update Posted (Estimate): February 8, 2013
• Last Update Submitted That Met QC Criteria: February 7, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: CTD1202