Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

NCT01730872 | Completed Phase 4 Results

• 1 other identifier: 12-270-0007
• Study Type: interventional
• Target: 16
• 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: Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness

Conditions

Chronic Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Ocular Itching Change From Baseline to Day 6

  7 minutes post-CAC

• Ocular 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 4 days.

Prednisolone

Tears Naturale II Ophthalmic Solution DRUG

one drop in each eye, four times/ day (QID) for 4 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

Results Point of Contact

• Title: Keith Lane
• Organization: Ora

klane@oraclinical.com

9786858900

Study Officials

• Gail Torkildsen, MD

  Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology

  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: November 15, 2012
• First Posted: November 21, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 19, 2019
• Results First Posted: June 19, 2019

Record last verified: 2019-06

Locations

US (1)