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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01639846
• Other study ID #: CTD1202
• Status: Completed
• Phase: Phase 2
• First received: July 11, 2012
• Last updated: February 7, 2013
• Start date: July 2012
• Est. completion date: August 2012

Study information

• Verified date: February 2013
• Source: C.T. Development America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
C.T. Development America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular itching	Ocular itching at defined timepoints up to 2 weeks	Baseline to day 14	No
Primary	Conjunctival redness	Conjunctival redness evaluated by the investigator at defined timepoints up to 2 weeks	Baseline to day 14	No
Secondary	Ciliary and episcleral redness	Ciliary and episcleral redness evaluated by the investigator at defined timepoints up to 2 weeks	Baseline to day 14	No
Secondary	Chemosis	Chemosis evaluated by the investigator at defined timepoints up to 2 weeks	Baseline to day 14	No
Secondary	Eyelid swelling	Eyelid swelling evaluated by the subject at defined timepoints up to 2 weeks	Baseline to day 14	No
Secondary	Tearing	Tearing evaluated by the subject at defined timepoints up to 2 weeks	Baseline to day 14	No