Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis
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ClinicalTrials.gov Identifier: NCT01860664 |
Recruitment Status
:
Terminated
(The Sponsor has stopped responding to calls and emails)
First Posted
: May 23, 2013
Last Update Posted
: August 18, 2017
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Condition or disease | Intervention/treatment | Phase |
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Allergic Conjunctivitis | Drug: hydrocortisone ophthalmic ointment 0.5% Drug: placebo | Phase 2 |
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 |

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

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860664
United States, Kentucky | |
Koffler Vision Group | |
Lexington, Kentucky, United States, 40509 |
Principal Investigator: | Paul Karpecki, OD | Clinical Research Director |
Responsible Party: | Koffler Vision Group |
ClinicalTrials.gov Identifier: | NCT01860664 History of Changes |
Other Study ID Numbers: |
F2012-05 |
First Posted: | May 23, 2013 Key Record Dates |
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 |