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

Primary Purpose

Allergic Conjunctivitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
RX-10045
Vehicle for RX-10045 arm
Sponsored by
C.T. Development America, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Andover Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RX-10045 active arm

Vehicle for RX-10045 arm

Arm Description

RX-10045 Ophthalmic Solution, 0.09%

Vehicle of RX-10045 Ophthalmic Solution

Outcomes

Primary Outcome Measures

Ocular itching
Ocular itching at defined timepoints up to 2 weeks
Conjunctival redness
Conjunctival redness evaluated by the investigator at defined timepoints up to 2 weeks

Secondary Outcome Measures

Ciliary and episcleral redness
Ciliary and episcleral redness evaluated by the investigator at defined timepoints up to 2 weeks
Chemosis
Chemosis evaluated by the investigator at defined timepoints up to 2 weeks
Eyelid swelling
Eyelid swelling evaluated by the subject at defined timepoints up to 2 weeks
Tearing
Tearing evaluated by the subject at defined timepoints up to 2 weeks

Full Information

First Posted
July 11, 2012
Last Updated
February 7, 2013
Sponsor
C.T. Development America, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01639846
Brief Title
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

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C.T. Development America, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RX-10045 active arm
Arm Type
Experimental
Arm Description
RX-10045 Ophthalmic Solution, 0.09%
Arm Title
Vehicle for RX-10045 arm
Arm Type
Placebo Comparator
Arm Description
Vehicle of RX-10045 Ophthalmic Solution
Intervention Type
Drug
Intervention Name(s)
RX-10045
Intervention Description
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
Intervention Name(s)
Vehicle for RX-10045 arm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ocular itching
Description
Ocular itching at defined timepoints up to 2 weeks
Time Frame
Baseline to day 14
Title
Conjunctival redness
Description
Conjunctival redness evaluated by the investigator at defined timepoints up to 2 weeks
Time Frame
Baseline to day 14
Secondary Outcome Measure Information:
Title
Ciliary and episcleral redness
Description
Ciliary and episcleral redness evaluated by the investigator at defined timepoints up to 2 weeks
Time Frame
Baseline to day 14
Title
Chemosis
Description
Chemosis evaluated by the investigator at defined timepoints up to 2 weeks
Time Frame
Baseline to day 14
Title
Eyelid swelling
Description
Eyelid swelling evaluated by the subject at defined timepoints up to 2 weeks
Time Frame
Baseline to day 14
Title
Tearing
Description
Tearing evaluated by the subject at defined timepoints up to 2 weeks
Time Frame
Baseline to day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects MUST: Have a positive history of ocular allergies Have a positive bilateral conjunctival allergen challenge (CAC) reaction Exclusion Criteria: Subjects MUST NOT: Have known contraindications or sensitivities to study medication or its components Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters Use a disallowed medication during the period indicated prior to the enrollment or during the study Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Torkildsen, MD
Organizational Affiliation
Andover Eye Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States

12. IPD Sharing Statement

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

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