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Completed

NCT Number: NCT01534195

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

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

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Andover Eye Associates

Andover, Massachusetts, 01810, United States

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone Sodium Phosphate Ophthalmic Solution 1%

Drug

One drop in each eye, four times/day for 8 days.

Tears Naturale II Ophthalmic Solution

Drug

one drop in each eye, four times/ day (QID) for 8 days

Primary outcomes

  1. Ocular Itching Change From Baseline to Day 11

    Time frame: 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 outcomes

  1. Conjunctival Redness Change From Baseline to Day 11

    Time frame: 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)

  2. Episcleral Redness Change From Baseline to Day 6

    Time frame: 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).

  3. Ciliary Redness Change From Baseline to Day 6

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

ORA, Inc.

Industry

Registry information

Official study title

A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge (CAC) Model

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Feb 16, 2012
Registry last updated
Mar 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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