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

NCT01639846 | Completed Phase 2

• 1 other identifier: CTD1202
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (2)

• Ocular itching

  Ocular itching at defined timepoints up to 2 weeks

  Baseline to day 14

• Conjunctival redness

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

  Baseline to day 14

Secondary Outcomes (4)

• Ciliary and episcleral redness

  Baseline to day 14

• Chemosis

  Baseline to day 14

• Eyelid swelling

  Baseline to day 14

• Tearing

  Baseline to day 14

Study Arms (2)

RX-10045 active arm

EXPERIMENTAL

RX-10045 Ophthalmic Solution, 0.09%

Drug: RX-10045

Vehicle for RX-10045 arm

PLACEBO COMPARATOR

Vehicle of RX-10045 Ophthalmic Solution

Drug: Vehicle for RX-10045 arm

Interventions

RX-10045 DRUG

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.

RX-10045 active arm

Vehicle for RX-10045 arm DRUG

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.

Vehicle for RX-10045 arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects MUST:
• Have a positive history of ocular allergies
• Have a positive bilateral conjunctival allergen challenge (CAC) reaction

You may not qualify if:

• 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

Sponsors & Collaborators

• C.T. Development America, Inc.: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

isopropyl 5,12-hydroxypentadeca-8,10-dien-6,14-diynoate

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Gail Torkildsen, MD

  Andover Eye Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 13, 2012
• Study Start: July 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 8, 2013

Record last verified: 2013-02

Locations

US (1)