- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02079649
Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis
August 7, 2015 updated by: Alcon Research
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
The purpose of this study is to evaluate two investigational ophthalmic solutions for reduction in ocular redness in subjects with allergic conjunctivitis.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
224
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AL-53817
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)
|
|
Experimental: AL-78843
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)
|
|
Active Comparator: Maxidex
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)
|
Other Names:
|
Placebo Comparator: Vehicle
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)
|
Inactive ingredients used for masking purposes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
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
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
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
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
|
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].
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trial Manager, Pharma, GCRA, Alcon Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
March 4, 2014
First Submitted That Met QC Criteria
March 4, 2014
First Posted (Estimate)
March 6, 2014
Study Record Updates
Last Update Posted (Estimate)
August 24, 2015
Last Update Submitted That Met QC Criteria
August 7, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Hypersensitivity
- Conjunctival Diseases
- Conjunctivitis
- Conjunctivitis, Allergic
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Dexamethasone
- Ophthalmic Solutions
- Pharmaceutical Solutions
Other Study ID Numbers
- C-12-069
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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