Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT01730872
First received: November 15, 2012
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,

Prednisolone, assessed by the following measures:

Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness


Condition Intervention Phase
Chronic Allergic Conjunctivitis
Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%
Drug: Tears Naturale II Ophthalmic Solution
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model

Resource links provided by NLM:


Further study details as provided by ORA, Inc.:

Primary Outcome Measures:
  • Inflammation [ Time Frame: 90 minutes post CAC ] [ Designated as safety issue: No ]
    Visit 3A compared to Visit 5A


Secondary Outcome Measures:
  • Ocular Itching [ Time Frame: 3 minutes post CAC ] [ Designated as safety issue: No ]
    Visit 3B compared to 5B

  • Ocular Redness [ Time Frame: 7 minutes post-CAC ] [ Designated as safety issue: No ]
    Visit 3B compared to 5B


Enrollment: 16
Study Start Date: November 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prednisolone
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%
One drop in each eye, four times/day for 4 days.
Placebo Comparator: Placebo
Tears Naturale II Ophthalmic Solution, 1%
Drug: Tears Naturale II Ophthalmic Solution
one drop in each eye, four times/ day (QID) for 4 days

Detailed Description:

Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 4 days between Visits 3 and 4.

Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 2 weeks

Controls:

Artificial Tears (Tears Naturale® II)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years of age & either sex, any race
  • Willing and able to follow all instructions
  • Positive history of ocular allergies
  • Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Exclusion Criteria:

  • Have planned surgery during trial period
  • Female currently pregnant, planning a pregnancy or lactating
  • Use of disallowed medications
  • Have ocular infections, or ocular conditions that could affect study parameters
  • Have moderate to severe dry eye
  • Have used an investigational drug or device within 30 days of start of study
  • Female that is currently pregnant, planning a pregnancy or lactating
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730872

Locations
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
ORA, Inc.
Investigators
Principal Investigator: Gail Torkildsen, MD Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology
  More Information

No publications provided

Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT01730872     History of Changes
Other Study ID Numbers: 12-270-0007
Study First Received: November 15, 2012
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ophthalmic Solutions
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 28, 2014