Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

Phase 4

Completed

• Conditions: Chronic Allergic Conjunctivitis
• Interventions: Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%; Drug: Tears Naturale II Ophthalmic Solution

• Registration Number: NCT01730872
• Lead Sponsor: ORA, Inc.

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)

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-15
• Study First Submitted QC: 2012-11-15
• Study First Posted: 2012-11-21
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2018-12-27
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-18
• Last Update Submitted: 2019-06-18
• Results First Posted: 2019-06-19
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisolone	Prednisolone Sodium Phosphate Ophthalmic Solution 1%	Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Placebo	Tears Naturale II Ophthalmic Solution	Tears Naturale II Ophthalmic Solution, 1%

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Andover Eye Associates; 🇺🇸 Andover, Massachusetts, United States