Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Allergic Conjunctivitis	Drug: hydrocortisone ophthalmic ointment 0.5%; Drug: placebo	Phase 2

Detailed Description:

Compare the safety and 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	15 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	Phase 2 EFFICACY AND SAFETY OF HYDROCORTISONE OPHTHALMIC OINTMENT - VERSUS PLACEBO IN THE TREATMENT OF ALLERGIC CONJUNCTIVITIS
Study Start Date :	May 2013
Actual Primary Completion Date :	May 2016
Actual Study Completion Date :	January 1, 2017

Arms and Interventions

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Arm	Intervention/treatment
Experimental: hydrocortisone ophthalmic ointment 0.5%; 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%; 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; Other Name: PF01335
Placebo Comparator: Placebo; mineral oil and white petrolatum	Drug: placebo; Mineral oil and white petrolatum

Outcome Measures

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Primary Outcome Measures :

1. Efficacy of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis [ Time Frame: 14 days ]
   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.

Secondary Outcome Measures :

1. Safety of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis [ Time Frame: 3 days, 14 days ]
   At each visit, the principal investigator or designated personnel determined to be medically qualified by the principal investigator will begin by querying for adverse events by asking each patient a general, non-directed question such as 'How have you been feeling since the last visit?' Directed questioning and examination will then be done as appropriate. All reported adverse events will be documented on the appropriate case report form.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

a) Diagnosis of allergic conjunctivitis. b) Must be at least 18 years of age c) Must be able and willing to comply with all treatment and follow up procedures d) Best corrected visual acuity of 0.3 logMAR or better (Snellen equivalent score of 20/40 or better) in each eye at Visit 1 e) Conjunctival redness score ≥1.5 in at least one eye at Visit 1 f) Subject reported itching assessment >2.0 in at least 1 eye at Visit 1 g) Mean IOP >8 and <24 in each eye h) If female of childbearing potential, are non-lactating and non-pregnant, and must be willing to use an approved birth control method for the duration of the study, and must have a negative urine pregnancy test. (Urine pregnancy test will be conducted at Visit 1 after subject completes Informed Consent Document prior to any study procedures being performed.) 5.4 Exclusion Criteria

1. Unwilling or unable to discontinue use of contact lens during the study
2. Uncontrolled medical conditions that may in the judgment of the investigator confound the study assessments or limit compliance.
3. Known sensitivity to corticosteroids or a known "steroid responder"
4. Known hypersensitivity to the study drugs or the components or contraindications to hydrocortisone ophthalmic ointment
5. Use of any systemic or topical ophthalmic antihistamine agents within 72 hours before visit 1, and that cannot be discontinued during the study
6. Participation in an ophthalmic drug or device research study within 30 days prior to entry in this study.
7. Regular use of systemic or topical ophthalmic non-steroidal anti-inflammatory agents (NSAID), and analgesics
8. Younger than 18 years of age, Male or Female
9. Unwilling to provide written informed consent
10. Unlikely to complete all study visits
11. Patients diagnosed with Glaucoma
12. 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.
13. Use of any concurrent therapies for allergic conjunctivitis, prescription or over the counter.

14. Prohibited medications include:

    1. topical ophthalmic or systemic corticosteroids
    2. topical ophthalmic/nasal antihistamines (72 hour washout period prior to baseline/screening visit and no use throughout duration of the study)
    3. artificial tears/ocular lubricants (72 hour washout period and no use throughout the duration of the study)
    4. topical ophthalmic/nasal steroids (14 day washout period prior to baseline/screening visit and no use throughout the duration of the study) (Washout period can begin after Informed Consent Document is completed by the subject.)

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Kentucky
Koffler Vision Group
Lexington, Kentucky, United States, 40509

Sponsors and Collaborators

Koffler Vision Group

Fera Pharmaceuticals, LLC

Investigators

Principal Investigator:	Paul Karpecki, OD	Clinical Research Director

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Koffler Vision Group
ClinicalTrials.gov Identifier:	NCT01860664 History of Changes
Other Study ID Numbers:	F2012-05
First Posted:	May 23, 2013
Last Update Posted:	August 18, 2017
Last Verified:	August 2017

Keywords provided by Koffler Vision Group:

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

Additional relevant MeSH terms:

Conjunctivitis; Conjunctivitis, Allergic; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Hydrocortisone 17-butyrate 21-propionate	Hydrocortisone acetate; Cortisol succinate; Hydrocortisone; Petrolatum; Mineral Oil; Anti-Inflammatory Agents; Emollients; Dermatologic Agents