Evaluation of the Onset and Duration of Action of RX-10045 in Allergic Conjunctivitis
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|ClinicalTrials.gov Identifier: NCT01639846|
Recruitment Status : Completed
First Posted : July 13, 2012
Last Update Posted : February 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Allergic Conjunctivitis||Drug: RX-10045 Drug: Vehicle for RX-10045 arm||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 Start Date :||July 2012|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||August 2012|
Experimental: RX-10045 active arm
RX-10045 Ophthalmic Solution, 0.09%
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.
- Ocular itching [ Time Frame: Baseline to day 14 ]Ocular itching at defined timepoints up to 2 weeks
- Conjunctival redness [ Time Frame: Baseline to day 14 ]Conjunctival redness evaluated by the investigator at defined timepoints up to 2 weeks
- Ciliary and episcleral redness [ Time Frame: Baseline to day 14 ]Ciliary and episcleral redness evaluated by the investigator at defined timepoints up to 2 weeks
- Chemosis [ Time Frame: Baseline to day 14 ]Chemosis evaluated by the investigator at defined timepoints up to 2 weeks
- Eyelid swelling [ Time Frame: Baseline to day 14 ]Eyelid swelling evaluated by the subject at defined timepoints up to 2 weeks
- Tearing [ Time Frame: Baseline to day 14 ]Tearing evaluated by the subject at defined timepoints up to 2 weeks
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639846
|United States, Massachusetts|
|Andover Eye Associates|
|Andover, Massachusetts, United States, 01810|
|Principal Investigator:||Gail Torkildsen, MD||Andover Eye Associates|