Efficacy and Safety of an Ophthalmic Solution in Patients With Allergic Conjunctivitis
This study is ongoing, but not recruiting participants.
Sponsor:
Alcon Research
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01743027
First received: December 4, 2012
Last updated: June 7, 2013
Last verified: June 2013
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Purpose
The purpose of this study is to evaluate an ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Conjunctivitis |
Drug: AL-4943A ophthalmic solution Other: AL-4943A ophthalmic solution vehicle Drug: Olopatadine hydrochloride ophthalmic solution, 0.2% Drug: Olopatadine hydrochloride ophthalmic solution, 0.1% |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Alcon Research:
Primary Outcome Measures:
- Ocular itching associated with allergic conjunctivitis at the 24 hours duration of action. [ Time Frame: Day 1 ] [ Designated as safety issue: No ]A CAC will be performed on Day 1, 24 hours after drop instillation on Day 0. Ocular itching will be assessed by the patient post-CAC.
- Ocular itching associated with allergic conjunctivitis at the onset of action [ Time Frame: Day 14 ] [ Designated as safety issue: No ]A CAC will be performed after drop instillation (Day 14). Ocular itching will be assessed by the patient pre-dose and post-CAC. This outcome measure is pre-specified for AL-4943A and AL-4943A Vehicle.
Secondary Outcome Measures:
- Conjunctival redness associated with allergic conjunctivitis at the onset of action [ Time Frame: Day 14 ] [ Designated as safety issue: No ]A CAC will be performed after drop instillation (Day 14). Conjunctival redness will be assessed by the investigator pre-dose and post-CAC. This outcome measure is pre-specified for AL-4943A, PATADAY and AL-4943A Vehicle.
- Total redness associated with allergic conjunctivitis at the onset of action [ Time Frame: Day 14 ] [ Designated as safety issue: No ]A CAC will be performed after drop instillation (Day 14). Total redness will be assessed by the investigator pre-dose and post-CAC. This outcome measure is pre-specified for AL-4943A, PATANOL, and PATADAY.
- Conjunctival redness associated with allergic conjunctivitis at the 24 hours duration of action [ Time Frame: Day 1 ] [ Designated as safety issue: No ]A CAC will be performed on Day 1, 24 hours after drop instillation on Day 0. Conjunctival redness will be assessed by the investigator post-CAC.
- Total redness associated with allergic conjunctivitis at the 24 hours duration of action [ Time Frame: Day 1 ] [ Designated as safety issue: No ]A CAC will be performed on Day 1, 24 hours after drop instillation on Day 0. Total redness will be assessed by the investigator post-CAC. This outcome measure is pre-specified for AL-4943A, PATANOL, and PATADAY.
- Proportion of ocular itching responders at the 24 hours duration of action [ Time Frame: Day 1 ] [ Designated as safety issue: No ]A CAC will be performed on Day 1, 24 hours after drop instillation on Day 0. Ocular itching will be assessed by the patient post-CAC. A responder is defined as a patient with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. This outcome measure is pre-specified for AL-4943A, PATANOL, and PATADAY.
- Proportion of ocular itching responders associated with allergic conjunctivitis at the onset of action [ Time Frame: Day 14 ] [ Designated as safety issue: No ]A CAC will be performed after drop instillation (Day 14). Ocular itching will be assessed by the patient pre-dose and post-CAC. A responder is defined as a patient with zero-itch (a score of zero on ocular itching for both eyes) or with at least 2 units reduction in ocular itching relative to the baseline confirmatory CAC score. This outcome measure is pre-specified for AL-4943A, PATANOL, and PATADAY.
- Ocular itching associated with allergic conjunctivitis at the 24 hours duration of action [ Time Frame: Day 1 ] [ Designated as safety issue: No ]A CAC will be performed on Day 1, 24 hours after drop instillation on Day 0. Ocular itching will be assessed by the patient post-CAC. This outcome measure is pre-specified for PATADAY and AL-4943A Vehicle.
| Estimated Enrollment: | 345 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: AL-4943A
AL-4943A ophthalmic solution, 1 drop per eye, 2 non-consecutive days
|
Drug: AL-4943A ophthalmic solution |
|
Placebo Comparator: AL-4943A Vehicle
AL-4943A ophthalmic solution vehicle, 1 drop per eye, 2 non-consecutive days
|
Other: AL-4943A ophthalmic solution vehicle |
|
Active Comparator: PATADAY
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye, 2 non-consecutive days
|
Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
Other Name: PATADAY®
|
|
Active Comparator: PATANOL
Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye, 2 non-consecutive days
|
Drug: Olopatadine hydrochloride ophthalmic solution, 0.1%
Other Name: PATANOL®
|
Detailed Description:
Enrolled participants will be tested for the presence of common allergies using the Conjunctival Allergen Challenge (CAC) model. Drops of increasing concentration of a solubilized allergen will be instilled in both eyes until a positive reaction occurs. The test will be repeated to confirm the allergic reaction. Participants with confirmed reactions will be administered the test article (Day 0) and undergo a CAC 24 hours post-instillation (Day 1). On Day 14, participants will be administered the test article and undergo an additional CAC.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
- Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.
- Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months prior to Visit 1 or at Visit 1.
- History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
- Best-corrected visual acuity of 55 or greater in each eye as measured by ETDRS (letters read method).
- Manifest a positive bilateral Conjunctival Allergen Challenge (CAC) test response.
- Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Known history or presence of persistent dry eye syndrome, or currently requires frequent use of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
- Presence of an ocular condition that may affect the study outcomes.
- History or evidence of ocular surgery (including refractive procedures such as LASIK, PRK and RK) within 6 months of Visit 1.
- Presence of signs/symptoms of active allergic conjunctivitis at the start of Visits 1, 2, 3A, or 4.
- History of anaphylactic reaction to any allergens used in this study.
- Current evidence or recent (within 6 months) history of severe, unstable, or uncontrolled medical conditions and/or other relevant systemic diseases.
- Use of any disallowed medication during the period indicated prior to Visit 1.
- Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743027
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: | Undraa Altangerel, MD | Alcon Research |
More Information
No publications provided
| Responsible Party: | Alcon Research |
| ClinicalTrials.gov Identifier: | NCT01743027 History of Changes |
| Other Study ID Numbers: | C-12-053 |
| Study First Received: | December 4, 2012 |
| Last Updated: | June 7, 2013 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Alcon Research:
|
Allergic conjunctivitis Olopatadine HCl solution Conjunctival Allergen Challenge Itching eyes |
Ocular allergies PATADAY PATANOL |
Additional relevant MeSH terms:
|
Conjunctivitis Conjunctivitis, Allergic Conjunctival Diseases Eye Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Olopatadine Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Allergic Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013