Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

Chronic Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01730872
• Other study ID #: 12-270-0007
• Status: Completed
• Phase: Phase 4
• Start date: November 2012
• Est. completion date: December 2012

Study information

• Verified date: June 2019
• Source: ORA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Prednisolone Sodium Phosphate Ophthalmic Solution 1%
One drop in each eye, four times/day for 4 days.
• Tears Naturale II Ophthalmic Solution
one drop in each eye, four times/ day (QID) for 4 days

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammation Change From Baseline to Day 6	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).	90 minutes post CAC
Secondary	Ocular Itching Change From Baseline to Day 6	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	7 minutes post-CAC
Secondary	Ocular Redness Change From Baseline to Day 6	Ocular redness was measured by the investigator on a 4-point scale 7 minutes post-CAC. 0 = best (no redness), 4 = worst (most redness).	7 minutes post-CAC