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

NCT01534195 | Completed Phase 4 Results

• 1 other identifier: 12-270-0001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Ocular Itching Change From Baseline to Day 11

  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).

  5 minutes post-CAC

Secondary Outcomes (3)

• Conjunctival Redness Change From Baseline to Day 11

  7 Minutes post-CAC

• Episcleral Redness Change From Baseline to Day 6

  7 minutes post-CAC

• Ciliary Redness Change From Baseline to Day 6

  7 minutes post-CAC

Study Arms (2)

Prednisolone

EXPERIMENTAL

Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%

Placebo

PLACEBO COMPARATOR

Tears Naturale II Ophthalmic Solution, 1%

Drug: Tears Naturale II Ophthalmic Solution

Interventions

Prednisolone Sodium Phosphate Ophthalmic Solution 1% DRUG

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

Prednisolone

Tears Naturale II Ophthalmic Solution DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ORA, Inc.: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Keith Lane
• Organization: Ora

klane@oraclinical.com

9786896500

Study Officials

• Tarek Shazly, MD

  Ophthalmic society of Egypt, Egyptian Glaucoma Society, American Acadamy of Ophthalmology, American Glaucoma Society, The association for research in vision and ophthalmology, international society of refractive surgery, Pan Arab Glaucoma Society

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2012
• First Posted: February 16, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: March 26, 2019
• Results First Posted: January 15, 2019

Record last verified: 2012-07

Locations

US (1)