search
Back to results

Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis

Primary Purpose

Allergic Conjunctivitis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
hydrocortisone ophthalmic ointment 0.5%
placebo
Sponsored by
Koffler Vision Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring allergy, allergic, conjunctivitis, corticosteroid, hydrocortisone, ophthalmic, ointment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Koffler Vision Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

hydrocortisone ophthalmic ointment 0.5%

Placebo

Arm Description

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

mineral oil and white petrolatum

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 20, 2013
Last Updated
August 15, 2017
Sponsor
Koffler Vision Group
Collaborators
Fera Pharmaceuticals, LLC
search

1. Study Identification

Unique Protocol Identification Number
NCT01860664
Brief Title
Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis
Official Title
Phase 2 EFFICACY AND SAFETY OF HYDROCORTISONE OPHTHALMIC OINTMENT - VERSUS PLACEBO IN THE TREATMENT OF ALLERGIC CONJUNCTIVITIS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
The Sponsor has stopped responding to calls and emails
Study Start Date
May 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koffler Vision Group
Collaborators
Fera Pharmaceuticals, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
allergy, allergic, conjunctivitis, corticosteroid, hydrocortisone, ophthalmic, ointment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hydrocortisone ophthalmic ointment 0.5%
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
mineral oil and white petrolatum
Intervention Type
Drug
Intervention Name(s)
hydrocortisone ophthalmic ointment 0.5%
Other Intervention Name(s)
PF01335
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Mineral oil and white petrolatum
Primary Outcome Measure Information:
Title
Efficacy of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Safety of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis
Description
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.
Time Frame
3 days, 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: topical ophthalmic or systemic corticosteroids topical ophthalmic/nasal antihistamines (72 hour washout period prior to baseline/screening visit and no use throughout duration of the study) artificial tears/ocular lubricants (72 hour washout period and no use throughout the duration of the study) 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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Karpecki, OD
Organizational Affiliation
Clinical Research Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
Koffler Vision Group
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis

We'll reach out to this number within 24 hrs