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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|