search
Back to results

Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

Primary Purpose

Chronic Allergic Conjunctivitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prednisolone Sodium Phosphate Ophthalmic Solution 1%
Tears Naturale II Ophthalmic Solution
Sponsored by
ORA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Allergic Conjunctivitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Andover Eye Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prednisolone

Placebo

Arm Description

Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Tears Naturale II Ophthalmic Solution, 1%

Outcomes

Primary Outcome Measures

Inflammation Change From Baseline to Day 6
Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).

Secondary Outcome Measures

Ocular Itching Change From Baseline to Day 6
Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC
Ocular Redness Change From Baseline to Day 6
Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).

Full Information

First Posted
November 15, 2012
Last Updated
June 18, 2019
Sponsor
ORA, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01730872
Brief Title
Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ORA, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Allergic Conjunctivitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prednisolone
Arm Type
Experimental
Arm Description
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tears Naturale II Ophthalmic Solution, 1%
Intervention Type
Drug
Intervention Name(s)
Prednisolone Sodium Phosphate Ophthalmic Solution 1%
Intervention Description
One drop in each eye, four times/day for 4 days.
Intervention Type
Drug
Intervention Name(s)
Tears Naturale II Ophthalmic Solution
Intervention Description
one drop in each eye, four times/ day (QID) for 4 days
Primary Outcome Measure Information:
Title
Inflammation Change From Baseline to Day 6
Description
Ocular inflammation was measured by a masked clinician on a 4-point scale 90 minutes after the conjunctival allergen challenge (CAC) . 0 = best (little to no inflammation), 4 = worst (most inflammation).
Time Frame
90 minutes post CAC
Secondary Outcome Measure Information:
Title
Ocular Itching Change From Baseline to Day 6
Description
Ocular itching was measured by subject on a scale of 0 to 4 where 0 = no itching and 4 = worst itching. This measurement was taken 7 minutes post CAC
Time Frame
7 minutes post-CAC
Title
Ocular Redness Change From Baseline to Day 6
Description
Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).
Time Frame
7 minutes post-CAC

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Torkildsen, MD
Organizational Affiliation
Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

We'll reach out to this number within 24 hrs