Allergic Conjunctivitis
Conditions
Keywords
Allergic conjunctivitis, Olopatadine HCl solution, Conjunctival Allergen Challenge, Itching eyes, Ocular allergies, PATADAY, PATANOL
Brief summary
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.
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 occurred. 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.
Interventions
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 without protocol-specified washout period prior to Visit 1, or during the study. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Ocular Itching at Onset of Action | Day 14 (3, 5, and 7 minutes post-CAC) | A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed. |
| Mean Ocular Itching at 24 Hours Duration of Action | Day 1 (3, 5, and 7 minutes post-CAC) | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Total Redness at Onset of Action | Day 14 (7, 15, and 20 minutes post-CAC) | A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed. |
| Mean Total Redness at 24 Hours Duration of Action | Day 1 (7, 15, and 20 minutes post-CAC) | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed. |
| Mean Conjunctival Redness at Onset of Action | Day 14 (7, 15, and 20 minutes post-CAC) | A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. |
| Proportion of Itch Responders at 24 Hours Duration of Action | Day 1 | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant 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. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage. |
| Proportion of Ocular Itching Responders at Onset of Action | Day 14 | A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant 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. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage. |
| Mean Conjunctival Redness at 24 Hours Duration of Action | Day 1 (7, 15, and 20 minutes post-CAC) | A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed. |
Participant flow
Recruitment details
Participants were recruited from 6 study centers located in the US.
Pre-assignment details
Of the 902 enrolled, 557 participants discontinued prior to randomization due to screen failure (390), adverse event (12), lost to follow-up (26), protocol violation (2), withdrawal by patient (85), and other (42). This reporting group includes all randomized participants (345).
Participants by arm
| Arm | Count |
|---|---|
| AL-4943A AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 | 98 |
| PATADAY Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 | 99 |
| PATANOL Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 | 99 |
| Vehicle AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14 | 49 |
| Total | 345 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 2 | 0 |
| Overall Study | Progressive Disease | 1 | 4 | 3 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | AL-4943A | PATADAY | PATANOL | Vehicle | Total |
|---|---|---|---|---|---|
| Age, Customized 18-64 Years | 97 participants | 93 participants | 95 participants | 48 participants | 333 participants |
| Age, Customized ≥65 - <75 Years | 1 participants | 5 participants | 4 participants | 1 participants | 11 participants |
| Age, Customized ≥75 - <85 Years | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Sex: Female, Male Female | 61 Participants | 55 Participants | 56 Participants | 32 Participants | 204 Participants |
| Sex: Female, Male Male | 37 Participants | 44 Participants | 43 Participants | 17 Participants | 141 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 98 | 0 / 99 | 0 / 99 | 0 / 49 |
| serious Total, serious adverse events | 0 / 98 | 0 / 99 | 0 / 99 | 0 / 49 |
Outcome results
Primary
Mean Ocular Itching at 24 Hours Duration of Action
A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Time frame: Day 1 (3, 5, and 7 minutes post-CAC)
Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AL-4943A | Mean Ocular Itching at 24 Hours Duration of Action | 3 minutes post-CAC | 1.01 units on a scale | Standard Error 0.093 |
| AL-4943A | Mean Ocular Itching at 24 Hours Duration of Action | 7 minutes post-CAC | 1.25 units on a scale | Standard Error 0.097 |
| AL-4943A | Mean Ocular Itching at 24 Hours Duration of Action | 5 minutes post-CAC | 1.22 units on a scale | Standard Error 0.092 |
| PATADAY | Mean Ocular Itching at 24 Hours Duration of Action | 3 minutes post-CAC | 1.33 units on a scale | Standard Error 0.093 |
| PATADAY | Mean Ocular Itching at 24 Hours Duration of Action | 7 minutes post-CAC | 1.41 units on a scale | Standard Error 0.097 |
| PATADAY | Mean Ocular Itching at 24 Hours Duration of Action | 5 minutes post-CAC | 1.48 units on a scale | Standard Error 0.092 |
| PATANOL | Mean Ocular Itching at 24 Hours Duration of Action | 5 minutes post-CAC | 1.70 units on a scale | Standard Error 0.091 |
| PATANOL | Mean Ocular Itching at 24 Hours Duration of Action | 3 minutes post-CAC | 1.53 units on a scale | Standard Error 0.093 |
| PATANOL | Mean Ocular Itching at 24 Hours Duration of Action | 7 minutes post-CAC | 1.64 units on a scale | Standard Error 0.096 |
| Vehicle | Mean Ocular Itching at 24 Hours Duration of Action | 3 minutes post-CAC | 2.30 units on a scale | Standard Error 0.132 |
| Vehicle | Mean Ocular Itching at 24 Hours Duration of Action | 7 minutes post-CAC | 2.14 units on a scale | Standard Error 0.137 |
| Vehicle | Mean Ocular Itching at 24 Hours Duration of Action | 5 minutes post-CAC | 2.37 units on a scale | Standard Error 0.13 |
Primary
Mean Ocular Itching at Onset of Action
A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). Average of ocular itching score over both eyes was analyzed.
Time frame: Day 14 (3, 5, and 7 minutes post-CAC)
Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AL-4943A | Mean Ocular Itching at Onset of Action | 3 minutes post-CAC | 0.38 units on a scale | Standard Error 0.069 |
| AL-4943A | Mean Ocular Itching at Onset of Action | 7 minutes post-CAC | 0.65 units on a scale | Standard Error 0.081 |
| AL-4943A | Mean Ocular Itching at Onset of Action | 5 minutes post-CAC | 0.53 units on a scale | Standard Error 0.075 |
| PATADAY | Mean Ocular Itching at Onset of Action | 3 minutes post-CAC | 0.47 units on a scale | Standard Error 0.069 |
| PATADAY | Mean Ocular Itching at Onset of Action | 7 minutes post-CAC | 0.61 units on a scale | Standard Error 0.082 |
| PATADAY | Mean Ocular Itching at Onset of Action | 5 minutes post-CAC | 0.61 units on a scale | Standard Error 0.075 |
| PATANOL | Mean Ocular Itching at Onset of Action | 5 minutes post-CAC | 0.79 units on a scale | Standard Error 0.076 |
| PATANOL | Mean Ocular Itching at Onset of Action | 3 minutes post-CAC | 0.59 units on a scale | Standard Error 0.07 |
| PATANOL | Mean Ocular Itching at Onset of Action | 7 minutes post-CAC | 0.83 units on a scale | Standard Error 0.083 |
| Vehicle | Mean Ocular Itching at Onset of Action | 3 minutes post-CAC | 1.91 units on a scale | Standard Error 0.095 |
| Vehicle | Mean Ocular Itching at Onset of Action | 7 minutes post-CAC | 1.82 units on a scale | Standard Error 0.113 |
| Vehicle | Mean Ocular Itching at Onset of Action | 5 minutes post-CAC | 1.99 units on a scale | Standard Error 0.103 |
Secondary
Mean Conjunctival Redness at 24 Hours Duration of Action
A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
Time frame: Day 1 (7, 15, and 20 minutes post-CAC)
Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AL-4943A | Mean Conjunctival Redness at 24 Hours Duration of Action | 15 minutes post-CAC | 2.04 units on a scale | Standard Error 0.073 |
| AL-4943A | Mean Conjunctival Redness at 24 Hours Duration of Action | 7 minutes post-CAC | 1.92 units on a scale | Standard Error 0.074 |
| AL-4943A | Mean Conjunctival Redness at 24 Hours Duration of Action | 20 minutes post-CAC | 2.08 units on a scale | Standard Error 0.078 |
| PATADAY | Mean Conjunctival Redness at 24 Hours Duration of Action | 7 minutes post-CAC | 2.01 units on a scale | Standard Error 0.073 |
| PATADAY | Mean Conjunctival Redness at 24 Hours Duration of Action | 15 minutes post-CAC | 2.21 units on a scale | Standard Error 0.073 |
| PATADAY | Mean Conjunctival Redness at 24 Hours Duration of Action | 20 minutes post-CAC | 2.19 units on a scale | Standard Error 0.078 |
| PATANOL | Mean Conjunctival Redness at 24 Hours Duration of Action | 7 minutes post-CAC | 1.97 units on a scale | Standard Error 0.073 |
| PATANOL | Mean Conjunctival Redness at 24 Hours Duration of Action | 20 minutes post-CAC | 2.07 units on a scale | Standard Error 0.077 |
| PATANOL | Mean Conjunctival Redness at 24 Hours Duration of Action | 15 minutes post-CAC | 2.10 units on a scale | Standard Error 0.073 |
| Vehicle | Mean Conjunctival Redness at 24 Hours Duration of Action | 15 minutes post-CAC | 2.22 units on a scale | Standard Error 0.104 |
| Vehicle | Mean Conjunctival Redness at 24 Hours Duration of Action | 7 minutes post-CAC | 2.09 units on a scale | Standard Error 0.104 |
| Vehicle | Mean Conjunctival Redness at 24 Hours Duration of Action | 20 minutes post-CAC | 2.23 units on a scale | Standard Error 0.11 |
Secondary
Mean Conjunctival Redness at Onset of Action
A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness was assessed by the investigator on a 0-4 scale (0=none, 4=extremely severe). Average of conjunctival redness score over both eyes was analyzed.
Time frame: Day 14 (7, 15, and 20 minutes post-CAC)
Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AL-4943A | Mean Conjunctival Redness at Onset of Action | 7 minutes post-CAC | 1.34 units on a scale | Standard Error 0.082 |
| AL-4943A | Mean Conjunctival Redness at Onset of Action | 20 minutes post-CAC | 1.66 units on a scale | Standard Error 0.082 |
| AL-4943A | Mean Conjunctival Redness at Onset of Action | 15 minutes post-CAC | 1.65 units on a scale | Standard Error 0.082 |
| PATADAY | Mean Conjunctival Redness at Onset of Action | 7 minutes post-CAC | 1.62 units on a scale | Standard Error 0.082 |
| PATADAY | Mean Conjunctival Redness at Onset of Action | 20 minutes post-CAC | 1.97 units on a scale | Standard Error 0.082 |
| PATADAY | Mean Conjunctival Redness at Onset of Action | 15 minutes post-CAC | 1.96 units on a scale | Standard Error 0.082 |
| PATANOL | Mean Conjunctival Redness at Onset of Action | 15 minutes post-CAC | 1.97 units on a scale | Standard Error 0.083 |
| PATANOL | Mean Conjunctival Redness at Onset of Action | 7 minutes post-CAC | 1.65 units on a scale | Standard Error 0.083 |
| PATANOL | Mean Conjunctival Redness at Onset of Action | 20 minutes post-CAC | 1.97 units on a scale | Standard Error 0.083 |
| Vehicle | Mean Conjunctival Redness at Onset of Action | 7 minutes post-CAC | 1.96 units on a scale | Standard Error 0.113 |
| Vehicle | Mean Conjunctival Redness at Onset of Action | 20 minutes post-CAC | 2.15 units on a scale | Standard Error 0.113 |
| Vehicle | Mean Conjunctival Redness at Onset of Action | 15 minutes post-CAC | 2.10 units on a scale | Standard Error 0.112 |
Secondary
Mean Total Redness at 24 Hours Duration of Action
A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.
Time frame: Day 1 (7, 15, and 20 minutes post-CAC)
Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AL-4943A | Mean Total Redness at 24 Hours Duration of Action | 7 minutes post-CAC | 5.39 units on a scale | Standard Error 0.214 |
| AL-4943A | Mean Total Redness at 24 Hours Duration of Action | 20 minutes post-CAC | 6.00 units on a scale | Standard Error 0.23 |
| AL-4943A | Mean Total Redness at 24 Hours Duration of Action | 15 minutes post-CAC | 5.87 units on a scale | Standard Error 0.216 |
| PATADAY | Mean Total Redness at 24 Hours Duration of Action | 7 minutes post-CAC | 5.77 units on a scale | Standard Error 0.213 |
| PATADAY | Mean Total Redness at 24 Hours Duration of Action | 20 minutes post-CAC | 6.41 units on a scale | Standard Error 0.228 |
| PATADAY | Mean Total Redness at 24 Hours Duration of Action | 15 minutes post-CAC | 6.42 units on a scale | Standard Error 0.215 |
| PATANOL | Mean Total Redness at 24 Hours Duration of Action | 15 minutes post-CAC | 6.11 units on a scale | Standard Error 0.215 |
| PATANOL | Mean Total Redness at 24 Hours Duration of Action | 7 minutes post-CAC | 5.66 units on a scale | Standard Error 0.212 |
| PATANOL | Mean Total Redness at 24 Hours Duration of Action | 20 minutes post-CAC | 6.02 units on a scale | Standard Error 0.228 |
| Vehicle | Mean Total Redness at 24 Hours Duration of Action | 7 minutes post-CAC | 6.12 units on a scale | Standard Error 0.302 |
| Vehicle | Mean Total Redness at 24 Hours Duration of Action | 20 minutes post-CAC | 6.49 units on a scale | Standard Error 0.325 |
| Vehicle | Mean Total Redness at 24 Hours Duration of Action | 15 minutes post-CAC | 6.49 units on a scale | Standard Error 0.306 |
Secondary
Mean Total Redness at Onset of Action
A treatment efficacy CAC was performed 27 minutes after drop installation. Conjunctival redness, ciliary redness, and episcleral redness were assessed by the investigator on 0-4 scale (0=none, 4=extremely severe). Total redness is a composite variable summing conjunctival redness, ciliary redness, and episcleral redness scores (resultant score 0-12). The average of total redness over both eyes was analyzed.
Time frame: Day 14 (7, 15, and 20 minutes post-CAC)
Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| AL-4943A | Mean Total Redness at Onset of Action | 7 minutes post-CAC | 3.92 units on a scale | Standard Error 0.239 |
| AL-4943A | Mean Total Redness at Onset of Action | 20 minutes post-CAC | 4.96 units on a scale | Standard Error 0.244 |
| AL-4943A | Mean Total Redness at Onset of Action | 15 minutes post-CAC | 4.80 units on a scale | Standard Error 0.24 |
| PATADAY | Mean Total Redness at Onset of Action | 7 minutes post-CAC | 4.73 units on a scale | Standard Error 0.24 |
| PATADAY | Mean Total Redness at Onset of Action | 20 minutes post-CAC | 5.88 units on a scale | Standard Error 0.245 |
| PATADAY | Mean Total Redness at Onset of Action | 15 minutes post-CAC | 5.73 units on a scale | Standard Error 0.24 |
| PATANOL | Mean Total Redness at Onset of Action | 15 minutes post-CAC | 5.85 units on a scale | Standard Error 0.243 |
| PATANOL | Mean Total Redness at Onset of Action | 7 minutes post-CAC | 4.82 units on a scale | Standard Error 0.243 |
| PATANOL | Mean Total Redness at Onset of Action | 20 minutes post-CAC | 5.88 units on a scale | Standard Error 0.248 |
| Vehicle | Mean Total Redness at Onset of Action | 7 minutes post-CAC | 5.93 units on a scale | Standard Error 0.33 |
| Vehicle | Mean Total Redness at Onset of Action | 20 minutes post-CAC | 6.67 units on a scale | Standard Error 0.337 |
| Vehicle | Mean Total Redness at Onset of Action | 15 minutes post-CAC | 6.50 units on a scale | Standard Error 0.33 |
Secondary
Proportion of Itch Responders at 24 Hours Duration of Action
A treatment efficacy CAC was performed 24 hours after drop instillation on Day 0. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant 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. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.
Time frame: Day 1
Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication.Patients with missing data were considered as nonresponders in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AL-4943A | Proportion of Itch Responders at 24 Hours Duration of Action | 40.8 percentage of participants |
| PATADAY | Proportion of Itch Responders at 24 Hours Duration of Action | 30.3 percentage of participants |
| PATANOL | Proportion of Itch Responders at 24 Hours Duration of Action | 26.3 percentage of participants |
| Vehicle | Proportion of Itch Responders at 24 Hours Duration of Action | 4.1 percentage of participants |
Secondary
Proportion of Ocular Itching Responders at Onset of Action
A treatment efficacy CAC was performed 27 minutes after drop installation. Ocular itching was assessed by the participant on a 0-4 scale (0= none, 4 = incapacitating itch). A responder was defined as a participant 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. Ocular itching score was averaged across both eyes and over the 3 post-CAC assessments (3, 5, and 7 minutes) for the calculation of units reduction. Proportion of Ocular Itching Responders is reported as a percentage.
Time frame: Day 14
Population: Intent to Treat (ITT): This analysis population includes all randomized patients who received study medication. Patients with missing data were considered as nonresponders in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AL-4943A | Proportion of Ocular Itching Responders at Onset of Action | 71.4 percentage of participants |
| PATADAY | Proportion of Ocular Itching Responders at Onset of Action | 73.7 percentage of participants |
| PATANOL | Proportion of Ocular Itching Responders at Onset of Action | 59.6 percentage of participants |
| Vehicle | Proportion of Ocular Itching Responders at Onset of Action | 10.2 percentage of participants |