Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis

NCT01860664 | Terminated Phase 2

• 1 other identifier: F2012-05
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and effectiveness of hydrocortisone ophthalmic ointment compared to placebo in the treatment of Allergic Conjunctivitis.

Conditions

Allergic Conjunctivitis

Keywords

allergy; allergic; conjunctivitis; corticosteroid; hydrocortisone; ophthalmic; ointment

Outcome Measures

Primary Outcomes (1)

• Efficacy of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis

  Demonstration of efficacy is a statistically significant improvement in itching on a 0 to 4 patient subjective assessment itch score compared to the vehicle arm and at least a 25% (or 1 full unit or more) improvement in itch scores. Efficacy for bulbar redness scores would be indicated by a statistically significant improvement in redness on a zero to 4 based on the investigators objective assessment compared to the vehicle group. Differences of at least 25% on the four point scale would be considered clinically significant when attained at the majority of time points.

  14 days

Secondary Outcomes (1)

• Safety of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis

  3 days, 14 days

Study Arms (2)

hydrocortisone ophthalmic ointment 0.5%

EXPERIMENTAL

Topical ophthalmic corticosteroid ointment, is produced in a concentration of 0.5% of hydrocortisone Acetate in a vehicle composed of mineral oil and white petrolatum

Drug: hydrocortisone ophthalmic ointment 0.5%

Placebo

PLACEBO COMPARATOR

mineral oil and white petrolatum

Drug: placebo

Interventions

hydrocortisone ophthalmic ointment 0.5% DRUG

* Patients will be instructed to apply Hydrocortisone Ophthalmic Ointment 0.5% or placebo in the lower cul de sac or lid margin BID * Patients will be instructed to not use the study medications at least 2 hours prior to their appointment. * Study medication dosing details: * 0.05 grams hydrocortisone per gram of combination product * each application equal to 1/20th of a gram * total amount of active ingredient applied to each eye per application = 0.0025 grams hydrocortisone * total amount hydrocortisone applied per eye per day = 0.005 grams hydrocortisone * Total amount of active ingredient applied per eye throughout duration of the two week study = 0.07 grams hydrocortisone

Also known as: PF01335

hydrocortisone ophthalmic ointment 0.5%

placebo DRUG

Mineral oil and white petrolatum

Placebo

Eligibility Criteria

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

You may not qualify if:

• Unwilling or unable to discontinue use of contact lens during the study
• Uncontrolled medical conditions that may in the judgment of the investigator confound the study assessments or limit compliance.
• Known sensitivity to corticosteroids or a known "steroid responder"
• Known hypersensitivity to the study drugs or the components or contraindications to hydrocortisone ophthalmic ointment
• Use of any systemic or topical ophthalmic antihistamine agents within 72 hours before visit 1, and that cannot be discontinued during the study
• Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study.
• Regular use of systemic or topical ophthalmic non-steroidal anti-inflammatory agents (NSAID), and analgesics
• Younger than 18 years of age, Male or Female
• Unwilling to provide written informed consent
• Unlikely to complete all study visits
• Patients diagnosed with Glaucoma
• History of any ocular condition that, in the opinion of the investigator, could affect study parameters including, but not limited to, glaucoma, blepharitis, meibomian gland disease, follicular conjunctivitis, and/or active ocular infection or inflammation.
• Use of any concurrent therapies for allergic conjunctivitis, prescription or over the counter.
• Prohibited medications include:
• topical ophthalmic or systemic corticosteroids

Sponsors & Collaborators

• Koffler Vision Group: lead
• Fera Pharmaceuticals, LLC: collaborator

Study Sites (1)

Koffler Vision Group

Lexington, Kentucky, 40509, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic; Hypersensitivity; Conjunctivitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Paul Karpecki, OD

  Clinical Research Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2013
• First Posted: May 23, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: January 1, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Locations

US (1)