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A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft as Measured by In-Vivo Confocal Microscopy

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ClinicalTrials.gov Identifier: NCT02308501
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
ORA, Inc.

Brief Summary:
A Single-Center Evaluation of the Anti-Inflammatory Effects of Lastacaft ® as Measured by In-Vivo Confocal Microscopy

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Lastacaft ® Drug: Tears Naturale ® Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Alcaftadine

Arm Intervention/treatment
Active Comparator: Lastacaft ®
One drop Lastacaft® in right eye and one drop Tears Naturale® in left eye once on Day 1 and once on Day 2
Drug: Lastacaft ®
Placebo Comparator: Tears Naturale ®
One drop Tears Naturale® in right eye and one drop Lastacaft® in left eye once on Day 1 and once on Day 2
Drug: Tears Naturale ®



Primary Outcome Measures :
  1. Conjunctival Inflammation [ Time Frame: Day 1 - Day 2 ]
    scored on a 0 to 4 scale, 0= none and 4= white blood cell adherence and migration


Secondary Outcome Measures :
  1. Ocular itching [ Time Frame: Day 1 - Day 2 ]
    scored on a 0 to 4 scale, 0=none and 4=incapacitating itch

  2. Ciliary, Conjunctival, and Episcleral redness [ Time Frame: Day 1 - Day 2 ]
    scored on a 0 to 4 scale, 0=none 4=extremely severe

  3. Eyelid swelling [ Time Frame: Day 1 - Day 2 ]
    scored on a 0 to 3 scale, 0=none 3=severe

  4. Chemosis [ Time Frame: Day 1 - Day 2 ]
    scored on a 0 to 4 scale, 0=none 4=severe



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a positive history of ocular allergies and a positive skin test to protocol defined allergens
  • Have a positive CAC reaction at Visit 1
  • Have a positive conjunctival inflammation score at Visit 1

Exclusion Criteria:

  • May not use disallowed medications in specified washout period
  • May not have an ocular or system disease the investigator feels with impact subject safety or trial parameters
  • May not have active ocular infection

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Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT02308501     History of Changes
Other Study ID Numbers: 14-100-0012
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dextrans
Alcaftadine
Anticoagulants
Plasma Substitutes
Blood Substitutes
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs