Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model
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|ClinicalTrials.gov Identifier: NCT01730872|
Recruitment Status : Completed
First Posted : November 21, 2012
Results First Posted : June 19, 2019
Last Update Posted : June 19, 2019
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|
|Chronic Allergic Conjunctivitis||Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1% Drug: Tears Naturale II Ophthalmic Solution||Phase 4|
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)
Approximately 2 weeks
Artificial Tears (Tears Naturale® II)
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||November 2012|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
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
- Inflammation Change From Baseline to Day 6 [ Time Frame: 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).
- Ocular Itching Change From Baseline to Day 6 [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730872
|United States, Massachusetts|
|Andover Eye Associates|
|Andover, Massachusetts, United States, 01810|
|Principal Investigator:||Gail Torkildsen, MD||Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology|