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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
C.T. Development America, Inc.
ClinicalTrials.gov Identifier:
NCT01639846
First received: July 11, 2012
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Allergic Conjunctivitis
Drug: RX-10045
Drug: Vehicle for RX-10045 arm
Phase 2

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

Resource links provided by NLM:


Further study details as provided by C.T. Development America, Inc.:

Primary Outcome Measures:
  • Ocular itching [ Time Frame: Baseline to day 14 ] [ Designated as safety issue: No ]
    Ocular itching at defined timepoints up to 2 weeks

  • Conjunctival redness [ Time Frame: Baseline to day 14 ] [ Designated as safety issue: No ]
    Conjunctival redness evaluated by the investigator at defined timepoints up to 2 weeks


Secondary Outcome Measures:
  • Ciliary and episcleral redness [ Time Frame: Baseline to day 14 ] [ Designated as safety issue: No ]
    Ciliary and episcleral redness evaluated by the investigator at defined timepoints up to 2 weeks

  • Chemosis [ Time Frame: Baseline to day 14 ] [ Designated as safety issue: No ]
    Chemosis evaluated by the investigator at defined timepoints up to 2 weeks

  • Eyelid swelling [ Time Frame: Baseline to day 14 ] [ Designated as safety issue: No ]
    Eyelid swelling evaluated by the subject at defined timepoints up to 2 weeks

  • Tearing [ Time Frame: Baseline to day 14 ] [ Designated as safety issue: No ]
    Tearing evaluated by the subject at defined timepoints up to 2 weeks


Enrollment: 60
Study Start Date: July 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639846

Locations
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
C.T. Development America, Inc.
Investigators
Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
  More Information

No publications provided

Responsible Party: C.T. Development America, Inc.
ClinicalTrials.gov Identifier: NCT01639846     History of Changes
Other Study ID Numbers: CTD1202
Study First Received: July 11, 2012
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014