Back to resultsSafety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
AL-53817 Ophthalmic Solution, 0.1%
AL-78843 Ophthalmic Solution, 0.03%
Dexamethasone Ophthalmic Suspension, 0.1%
AL-53817 Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Allergic conjunctivitis, Red eyes, Eyelid swelling, Ragweed, Allergies, Itchy eyes, Ocular redness, Chemosis, Tearing, Watery eyes
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
AL-53817
AL-78843
Maxidex
Vehicle
Arm 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)
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)
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)
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)
Outcomes
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
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.
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
Ocular itching was assessed by the subject with both eyes rated together and scored on a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub). 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].
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02079649
Brief Title
Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
Allergic conjunctivitis, Red eyes, Eyelid swelling, Ragweed, Allergies, Itchy eyes, Ocular redness, Chemosis, Tearing, Watery eyes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
224 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AL-53817
Arm Type
Experimental
Arm 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)
Arm Title
AL-78843
Arm Type
Experimental
Arm 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)
Arm Title
Maxidex
Arm Type
Active Comparator
Arm 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)
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
AL-53817 Ophthalmic Solution, 0.1%
Intervention Type
Drug
Intervention Name(s)
AL-78843 Ophthalmic Solution, 0.03%
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Ophthalmic Suspension, 0.1%
Other Intervention Name(s)
Maxidex®
Intervention Type
Drug
Intervention Name(s)
AL-53817 Vehicle
Intervention Description
Inactive ingredients used for masking purposes
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7
Description
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.
Time Frame
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 Information:
Title
Mean Change From Baseline in Ocular Itching, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)] at Day 7
Description
Ocular itching was assessed by the subject with both eyes rated together and scored on a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub). 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].
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Manager, Pharma, GCRA
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
28007090
Citation
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.
Results Reference
derived
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Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis
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