Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model

Phase 4

Completed

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

• Registration Number: NCT01534195
• 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:

* 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 8 days between Visits 4 and 5.

* Prednisolone phosphate

* Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 19 days

Controls:

Artificial Tears (Tears Naturale® II)

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-25
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Study First Submitted QC: 2012-02-13
• Study First Posted: 2012-02-16
• Status Verified: 2012-07
• Results First Submitted: 2018-12-27
• Results First Submitted QC: 2018-12-27
• Results First Posted: 2019-01-15
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Primary Outcome Measures

Name	Time	Method
Ocular Itching Change From Baseline to Day 11	5 minutes post-CAC	Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).

Secondary Outcome Measures

Name	Time	Method
Episcleral Redness Change From Baseline to Day 6	7 minutes post-CAC	Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness).
Ciliary Redness Change From Baseline to Day 6	7 minutes post-CAC	Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness).
Conjunctival Redness Change From Baseline to Day 11	7 Minutes post-CAC	Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness)

Trial Locations

Locations (1)

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