CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 16 enrolled
Drug / intervention
Prednisolone Sodium Phosphate Ophthalmic Solution 1% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01730872
NCT01730872Phase 4Completed
CompareCT.gov

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

ORA, Inc.·interventional·Posted Nov 21, 2012·Updated Jun 19, 2019

In Brief

A Phase 4 clinical trial evaluating Prednisolone Sodium Phosphate Ophthalmic Solution 1% and Tears Naturale II Ophthalmic Solution for Chronic Allergic Conjunctivitis. Completed, enrolled 16 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Allergic Conjunctivitis
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 21, 2012
Enrollment StartNov 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 13.6 years ago

Interventions

Prednisolone Sodium Phosphate Ophthalmic Solution 1%drug

One drop in each eye, four times/day for 4 days.

Tears Naturale II Ophthalmic Solutiondrug

one drop in each eye, four times/ day (QID) for 4 days