Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model
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 |
---|---|---|
|
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
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
- 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
- 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
- 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
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.- 12-270-0007
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
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)
|
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)
|
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
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 |
klane@oraclinical.com |
- 12-270-0007