Allergic Conjunctivitis Clinical Trial
Official title:
Phase 2 EFFICACY AND SAFETY OF HYDROCORTISONE OPHTHALMIC OINTMENT - VERSUS PLACEBO IN THE TREATMENT OF ALLERGIC CONJUNCTIVITIS
Verified date | August 2017 |
Source | Koffler Vision Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 15 |
Est. completion date | January 1, 2017 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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.) |
Country | Name | City | State |
---|---|---|---|
United States | Koffler Vision Group | Lexington | Kentucky |
Lead Sponsor | Collaborator |
---|---|
Koffler Vision Group | Fera Pharmaceuticals, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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. | 3 days, 14 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03660878 -
A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis
|
Phase 1/Phase 2 | |
Completed |
NCT03682965 -
Texan Allergy & Sinus Center Mountain Cedar Intra-Lymphatic Immunotherapy Study
|
Phase 2 | |
Completed |
NCT01697969 -
Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients
|
Phase 4 | |
Completed |
NCT01685242 -
A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle
|
Phase 3 | |
Completed |
NCT01439815 -
An Allergen BioCube (ABC) Study Evaluating the Efficacy of Fluticasone Propionate Nasal Spray Compared to Placebo
|
Phase 4 | |
Completed |
NCT01294969 -
Patient Perception Study for AL-4943A
|
Phase 4 | |
Completed |
NCT01471184 -
The Effects of Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops Compared to Placebo
|
Phase 1 | |
Completed |
NCT00609128 -
Effect of Olopatadine on Allergic Tear Mediators
|
N/A | |
Recruiting |
NCT05969236 -
A Study of MDI-1228_mesylate Ophthalmic Solution in Healthy Adults
|
Phase 1 | |
Active, not recruiting |
NCT04619017 -
Airway Immune Response to Allergens (Use Lay Language Here)
|
Phase 1 | |
Not yet recruiting |
NCT01012752 -
A Multicenter Study to Evaluate Safety and Efficacy of Specific Immunotherapy With Modified Allergen Extracts
|
Phase 3 | |
Completed |
NCT01754766 -
AGN-229666 for the Treatment of Allergic Conjunctivitis
|
Phase 2 | |
Completed |
NCT01698814 -
A Six-Week Safety Study of an Investigational Ophthalmic Solution
|
Phase 3 | |
Completed |
NCT01443442 -
Bepreve vs. Alrex in Subjects With Moderate to Severe Allergic Conjunctivitis
|
Phase 4 | |
Completed |
NCT01203540 -
Evaluation of the Effect and Tolerance of Preservative Free NAAGA on the Inflammatory Component and Symptoms of Dry Eye Syndrome in Allergic Conjunctivitis Patients
|
Phase 4 | |
Completed |
NCT00987272 -
Study of Olopatadine HCl Ophthalmic Solutions Compared to Vehicle Using the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis in Japanese Subjects
|
Phase 3 | |
Completed |
NCT00769886 -
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.
|
Phase 3 | |
Completed |
NCT00534794 -
Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis
|
Phase 4 | |
Completed |
NCT00569777 -
Safety Study of a Contact Lens With Ketotifen in Healthy, Normal Volunteers
|
Phase 3 | |
Completed |
NCT00586664 -
Efficacy and Safety Study of Bepotastine Besilate Ophthalmic Solution in Allergic Conjunctivitis
|
Phase 3 |