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

NCT02079649 | Completed Phase 2 Results

• 1 other identifier: C-12-069
• Study Type: interventional
• Target: 224
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Allergic Conjunctivitis

Keywords

Allergic conjunctivitis; Red eyes; Eyelid swelling; Ragweed; Allergies; Itchy eyes; Ocular redness; Chemosis; Tearing; Watery eyes

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7

  Ocular redness ratings were collected for nasal and temporal areas of each eye and assessed by investigational center staff using a visual scale (ie, scored by comparing the subject's eye with a series of photographs) and graded on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. AUC was calculated using the trapezoidal rule with unequal intervals as determined by the assessment time points. Change was calculated as AUC(0-10)\[Day 7\] - AUC(0-10) \[Baseline\]. Both eyes contributed to the analysis.

  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 Outcomes (1)

• 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

Study Arms (4)

AL-53817

EXPERIMENTAL

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)

Drug: AL-53817 Ophthalmic Solution, 0.1%

AL-78843

EXPERIMENTAL

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)

Drug: AL-78843 Ophthalmic Solution, 0.03%

Maxidex

ACTIVE COMPARATOR

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)

Drug: Dexamethasone Ophthalmic Suspension, 0.1%

Vehicle

PLACEBO COMPARATOR

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)

Drug: AL-53817 Vehicle

Interventions

AL-53817 Ophthalmic Solution, 0.1% DRUG

AL-53817

AL-78843 Ophthalmic Solution, 0.03% DRUG

AL-78843

Dexamethasone Ophthalmic Suspension, 0.1% DRUG

Also known as: Maxidex®

Maxidex

AL-53817 Vehicle DRUG

Inactive ingredients used for masking purposes

Vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alcon Research: lead

Related Publications (1)

• Jacobs RL, Ramirez DA, Rather CG, Andrews CP, Jupiter DC, Trujillo F, Shulman DG. Redness response phenotypes of allergic conjunctivitis in an allergen challenge chamber. Ann Allergy Asthma Immunol. 2017 Jan;118(1):86-93.e2. doi: 10.1016/j.anai.2016.10.023.

  PMID: 28007090 DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic; Hypersensitivity; Lacerations

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Immune System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Clinical Project Lead, Pharma, GCRA
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Clinical Trial Manager, Pharma, GCRA

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 6, 2014
• Study Start: April 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 24, 2015
• Results First Posted: August 6, 2015

Record last verified: 2015-08