Hydrocortisone Ophthalmic Ointment 0.5% for Treatment of Allergic Conjunctivitis

NCT ID: NCT01860664

Last Updated: 2017-08-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2017-01-01

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.

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

hydrocortisone ophthalmic ointment 0.5%

Intervention Type: DRUG

• 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

Placebo

mineral oil and white petrolatum

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Mineral oil and white petrolatum

Interventions

hydrocortisone ophthalmic ointment 0.5%

• 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

placebo

Mineral oil and white petrolatum

Intervention Type: DRUG

Other Intervention Names

PF01335

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fera Pharmaceuticals, LLC

UNKNOWN

Sponsor Role: collaborator

Koffler Vision Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Karpecki, OD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Director

Locations

Koffler Vision Group

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

F2012-05

Identifier Type: -

Identifier Source: org_study_id