Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis
Information source: Koffler Vision Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Conjunctivitis
Intervention: hydrocortisone ophthalmic ointment 0.5% (Drug); placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Koffler Vision Group Official(s) and/or principal investigator(s):
Paul Karpecki, OD, Principal Investigator, Affiliation: Clinical Research Director
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.
Clinical Details
Official title: Phase 2 EFFICACY AND SAFETY OF HYDROCORTISONE OPHTHALMIC OINTMENT - VERSUS PLACEBO IN THE TREATMENT OF ALLERGIC CONJUNCTIVITIS
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Efficacy of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with allergic conjunctivitis
Secondary outcome: Safety of Hydrocortisone Ophthalmic Ointment 0.5% vs. Placebo for the reduction of signs and symptoms associated with 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.)
Locations and Contacts
Koffler Vision Group, Lexington, Kentucky 40509, United States; Recruiting
Melissa Barnes, Phone: 859-263-4631, Email: mbarnes@kofflervisiongroup.com
Paul Karpecki, OD, Principal Investigator
Additional Information
Starting date: May 2013
Last updated: January 2, 2015
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