Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis

A Prospective, Randomized, Double-Masked, Vehicle and Active-Controlled, Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for the Treatment of Allergic Conjunctivitis in an Environmental Exposure Chamber (EEC) Model

Sponsors

Lead Sponsor: Alcon Research

Source Alcon Research
Brief Summary

The purpose of this study is to evaluate two investigational ophthalmic solutions for reduction in ocular redness in subjects with allergic conjunctivitis.

Detailed Description

Eligible subjects attended 8 study visits, 5 of which included a 3-hour period of ragweed exposure in an Environmental Exposure Chamber. At the sixth visit, subjects received study product and began dosing for up to 9 days. The final visit was the final day of dosing. Participation in this study lasted up to 68 days.

Overall Status Completed
Start Date April 2014
Completion Date July 2014
Primary Completion Date July 2014
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7
Secondary Outcome
Measure Time Frame
Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7 0.0, 0.25, 0.50, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, and 10.0 hours on Days 1 (baseline) and 7
Enrollment 224
Condition
Intervention

Intervention Type: Drug

Intervention Name: AL-53817 Ophthalmic Solution, 0.1%

Arm Group Label: AL-53817

Intervention Type: Drug

Intervention Name: AL-78843 Ophthalmic Solution, 0.03%

Arm Group Label: AL-78843

Intervention Type: Drug

Intervention Name: Dexamethasone Ophthalmic Suspension, 0.1%

Arm Group Label: Maxidex

Other Name: Maxidex®

Intervention Type: Drug

Intervention Name: AL-53817 Vehicle

Description: Inactive ingredients used for masking purposes

Arm Group Label: Vehicle

Eligibility

Criteria:

Inclusion Criteria:

- Sign Informed Consent

- Use of condom by sexually active males for the entire duration of the study.

- Best corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).

- Able and willing to comply with study protocol and follow protocol instructions.

- Able to avoid any of the topical ocular or systemic excluded medications during the entire study period.

- At least 1 year subject-reported or physician-diagnosed history (prior to Screen Visit) of allergic conjunctivitis during the ragweed season.

- Positive skin prick test for short ragweed allergen within 12 months prior to Screen Visit.

- Significant staff-assessed ocular redness in at least one region in each eye within the 3 hour period of allergen exposure in the EEC (Screen Visits).

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for at least 1 week following the last dose of investigational product.

- Presence of any ocular infection, history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye.

- History of any ocular infection, physician or subject diagnosed, within 30 days prior to Screen Visit.

- Presence of glaucoma, past history of, or diagnosis of glaucoma or ocular hypertension.

- Presence of blepharitis, active rosacea affecting the ocular adnexa, meibomian gland dysfunction, follicular conjunctivitis, intraocular inflammation, or preauricular lymphadenopathy or any other ophthalmic abnormality that may affect the study outcomes.

- Corneal conditions affecting the corneal structure.

- Unwilling to discontinue contact lens wear during the study period.

- Any ocular surgery including ocular laser procedures within 1 year prior to Screen Visit.

- Current or recent (<6 months prior to Screen Visit) history of severe, unstable, or uncontrolled autoimmune, neurological, cardiovascular, hematological, hepatic, renal, psychological, respiratory, gastrointestinal and/or immunological disease or evidence of other diseases based upon a review of medical history and/or physical examination that, in the opinion of the Investigator, would preclude safe subject participation in the study.

- Receiving treatment for anxiety and/or depression at the Screen Visit; any history of suicide attempt.

- Participation in any investigational study within 30 days of Screen Visit or concomitantly with this study.

- Known contraindications or hypersensitivities to any of the study medications or their components

- Confirmed (by physician or optometrist) diagnosis of dry eye.

- History of sensitivity or adverse reaction to steroids.

- Known allergic reaction that is unresponsive to corticosteroids or non-steroidal anti-inflammatory drugs (NSAIDS).

- Physician diagnosed asthma (except inactive childhood asthma and exercise-induced asthma).

- Evidence of active inflammation in the eye as determined by the dilated fundus examination conducted at Screen C Visit.

- Any corneal swelling or haze as determined by the slitlamp examination conducted at Screen C Visit.

- Other protocol-defined exclusion criteria may apply.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Clinical Trial Manager, Pharma, GCRA Study Director Alcon Research
Verification Date

August 2015

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: AL-53817

Type: Experimental

Description: AL-53817 Ophthalmic Solution, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)

Label: AL-78843

Type: Experimental

Description: AL-78843 Ophthalmic Solution, 0.03%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)

Label: Maxidex

Type: Active Comparator

Description: Dexamethasone Ophthalmic Suspension, 0.1%, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)

Label: Vehicle

Type: Placebo Comparator

Description: AL-53817 Vehicle, 1 drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov