Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

Sponsor
ORA, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01730872
Collaborator
(none)
16
1
2
30
16.2

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%
  • Drug: Tears Naturale II Ophthalmic Solution
Phase 4

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)

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Inflammation Change From Baseline to Day 6 [90 minutes post CAC]

    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

  1. Ocular Itching Change From Baseline to Day 6 [7 minutes post-CAC]

    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

  2. Ocular Redness Change From Baseline to Day 6 [7 minutes post-CAC]

    Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT01730872
Other Study ID Numbers:
  • 12-270-0007
First Posted:
Nov 21, 2012
Last Update Posted:
Jun 19, 2019
Last Verified:
Jun 1, 2019

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Prednisolone Placebo Control
Arm/Group Description Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days. Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days Subjects received CAC using saline instead of allergen
Period Title: Overall Study
STARTED 8 5 3
Full Analysis Set 8 4 0
COMPLETED 8 5 3
NOT COMPLETED 0 0 0

Baseline Characteristics

Arm/Group Title Prednisolone Placebo Saline Total
Arm/Group Description Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days. Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days A group of three allergic subjects will be challenged with saline only to evaluate the impact of confocal microscopy on ocular signs and symptoms in the absence of allergic challenge. These five subjects will receive placebo in an open label fashion and will not require randomization. Total of all reporting groups
Overall Participants 8 5 3 16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
41.75
(1.461897)
37.2
(1.830301)
39.33
(0.905539)
39.88
(0.0707107)
Sex: Female, Male (Count of Participants)
Female
3
37.5%
2
40%
2
66.7%
7
43.8%
Male
5
62.5%
3
60%
1
33.3%
9
56.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
1
20%
0
0%
1
6.3%
Asian
0
0%
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
Black or African American
1
12.5%
0
0%
0
0%
1
6.3%
White
6
75%
4
80%
3
100%
13
81.3%
More than one race
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
1
12.5%
0
0%
0
0%
1
6.3%

Outcome Measures

1. Primary Outcome
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

Outcome Measure Data

Analysis Population Description
The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.
Arm/Group Title Prednisolone Placebo
Arm/Group Description Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days. Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days
Measure Participants 8 4
Mean (Standard Deviation) [score on a scale]
-1.2
(0.78)
-0.19
(0.43)
2. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.
Arm/Group Title Prednisolone Placebo
Arm/Group Description Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days. Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days
Measure Participants 8 4
Mean (Standard Deviation) [score on a scale]
-1.1
(1.30)
-1.0
(1.29)
3. Secondary Outcome
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

Outcome Measure Data

Analysis Population Description
The per-protocol (PP) population will comprise all subjects in the ITT population without protocol deviations.
Arm/Group Title Prednisolone Placebo
Arm/Group Description Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days. Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days
Measure Participants 8 4
Mean (Standard Deviation) [score on a scale]
-1.1
(1.38)
0.31
(1.01)

Adverse Events

Time Frame AEs were collected from the signing of the informed consent form to the end of the study (approximately 2 weeks).
Adverse Event Reporting Description
Arm/Group Title Prednisolone Placebo Saline
Arm/Group Description Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Prednisolone Sodium Phosphate Ophthalmic Solution 1%: One drop in each eye, four times/day for 4 days. Tears Naturale II Ophthalmic Solution, 1% Tears Naturale II Ophthalmic Solution: one drop in each eye, four times/ day (QID) for 4 days A group of five allergic subjects will be challenged with saline only to evaluate the impact of confocal microscopy on ocular signs and symptoms in the absence of allergic challenge. These five subjects will receive placebo in an open label fashion and will not require randomization.
All Cause Mortality
Prednisolone Placebo Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/8 (0%) 0/5 (0%) 0/3 (0%)
Serious Adverse Events
Prednisolone Placebo Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/8 (0%) 0/5 (0%) 0/3 (0%)
Other (Not Including Serious) Adverse Events
Prednisolone Placebo Saline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 2/8 (25%) 1/5 (20%) 0/3 (0%)
Eye disorders
peri-ocular lid redness 1/8 (12.5%) 1 0/5 (0%) 0 0/3 (0%) 0
endothelial pigment 0/8 (0%) 0 1/5 (20%) 1 0/3 (0%) 0
Musculoskeletal and connective tissue disorders
lower leg pain 1/8 (12.5%) 1 0/5 (0%) 0 0/3 (0%) 0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Keith Lane
Organization Ora
Phone 9786858900
Email klane@oraclinical.com
Responsible Party:
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT01730872
Other Study ID Numbers:
  • 12-270-0007
First Posted:
Nov 21, 2012
Last Update Posted:
Jun 19, 2019
Last Verified:
Jun 1, 2019