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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT02079649
First received: March 4, 2014
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate two investigational ophthalmic solutions for reduction in ocular redness in subjects with allergic conjunctivitis. Eligible subjects will attend 8 study visits, 5 of which include a 3-hour period of ragweed exposure in an Environmental Exposure Chamber. At the sixth visit, subjects will receive study product and begin dosing for up to 9 days. The final visit will be the final day of dosing. Participation in this study will last up to 68 days.


Condition Intervention Phase
Allergic Conjunctivitis
Drug: AL-53817 Ophthalmic Solution
Drug: AL-78843 Ophthalmic Solution
Drug: 0.1% Dexamethasone Ophthalmic Suspension
Drug: AL-53817 Vehicle Ophthalmic Solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change from Baseline in Ocular Redness, Area Under the Curve from Time Zero to Hour 10 [AUC (0-10)] at Day 7 [ Time Frame: Baseline, Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean Change from Baseline in Ocular Itching, Area Under the Curve from Time Zero to Hour 10 [AUC (0-10)] at Day 7 [ Time Frame: Baseline, Day 7 ] [ Designated as safety issue: No ]

Enrollment: 224
Study Start Date: April 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AL-53817
AL-53817 Ophthalmic Solution, 1 drop per eye twice a day for 6 to 8 days and 1 drop per eye one time on the last day of dosing (Day 7, 8 or 9)
Drug: AL-53817 Ophthalmic Solution
Experimental: AL-78843
AL-78843 Ophthalmic Solution, 1 drop per eye twice a day for 6 to 8 days and 1 drop per eye one time on the last day of dosing (Day 7, 8 or 9)
Drug: AL-78843 Ophthalmic Solution
Active Comparator: Maxidex
0.1% Dexamethasone Ophthalmic Suspension, 1 drop per eye twice a day for 6 to 8 days and 1 drop per eye one time on the last day of dosing (Day 7, 8 or 9)
Drug: 0.1% Dexamethasone Ophthalmic Suspension
Other Name: Maxidex®
Placebo Comparator: Vehicle
AL-53817 Vehicle Ophthalmic Solution, 1 drop per eye twice a day for 6 to 8 days and 1 drop per eye one time on the last day of dosing (Day 7, 8 or 9)
Drug: AL-53817 Vehicle Ophthalmic Solution
Inactive ingredients used as placebo comparator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02079649

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Kay Fisk, RN, BSN Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02079649     History of Changes
Other Study ID Numbers: C-12-069
Study First Received: March 4, 2014
Last Updated: July 28, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
Allergic conjunctivitis
Red eyes
Eyelid swelling
Ragweed
Allergies
Itchy eyes
Ocular redness
Chemosis
Tearing
Watery eyes

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014