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| Name | Class |
|---|---|
| Fera Pharmaceuticals, LLC | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hydrocortisone ophthalmic ointment 0.5% | Experimental | 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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| Placebo | Placebo Comparator | mineral oil and white petrolatum |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrocortisone ophthalmic ointment 0.5% | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Karpecki, OD | Clinical Research Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koffler Vision Group | Lexington | Kentucky | 40509 | United States |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| D006967 | Hypersensitivity |
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
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| placebo | Drug | Mineral oil and white petrolatum |
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| 3 days, 14 days |