Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis - Full Text View

Purpose

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	Intervention	Phase
Allergic Conjunctivitis	Drug: hydrocortisone ophthalmic ointment 0.5% Drug: placebo	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Phase 2 EFFICACY AND SAFETY OF HYDROCORTISONE OPHTHALMIC OINTMENT - VERSUS PLACEBO IN THE TREATMENT OF ALLERGIC CONJUNCTIVITIS

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Hydrocortisone cypionate Hydrocortisone valerate Hydrocortisone probutate Proctofoam-HC

U.S. FDA Resources

Further study details as provided by Koffler Vision Group:

Primary Outcome Measures:

Efficacy of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis [ Time Frame: 14 days ] [ Designated as safety issue: No ]
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:

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 ] [ Designated as safety issue: Yes ]
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.


Estimated Enrollment:	25
Study Start Date:	May 2013
Estimated Study Completion Date:	May 2016
Estimated Primary Completion Date:	March 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: hydrocortisone ophthalmic ointment 0.5%	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
Placebo Comparator: Placebo	Drug: placebo

Arms

Assigned Interventions

Active Comparator: hydrocortisone ophthalmic ointment 0.5%

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

Placebo Comparator: Placebo

Drug: placebo

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

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:
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01860664

Locations


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

Sponsors and Collaborators

Koffler Vision Group

Fera Development, LLC

Investigators


Principal Investigator:	Paul Karpecki, OD	Clinical Research Director

More Information


Responsible Party:	Koffler Vision Group
ClinicalTrials.gov Identifier:	NCT01860664 History of Changes
Other Study ID Numbers:	F2012-05
Study First Received:	May 20, 2013
Last Updated:	February 24, 2016
Health Authority:	United States: Food and Drug Administration

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 Cortisol succinate Hydrocortisone acetate Hydrocortisone Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on September 23, 2016