Allergic Conjunctivitis
Conditions
Keywords
Allergies, Ocular
Brief summary
The purpose of this study is to evaluate olopatadine 0.2% QD (once per day) compared to olopatadine 0.1% BID (twice per day) in the treatment of ocular itching associated with allergic conjunctivitis.
Interventions
DRUGOlopatadine Hydrochloride Ophthalmic Solution 0.2%
Inactive ingredients used as placebo comparator
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chinese ethnicity; * History of allergic conjunctivitis within the last 2 years; * Positive skin prick test or skin intradermal test documented by a lab report within 24 months of, or at the baseline visit; * Clinical diagnosis of allergic conjunctivitis with specific signs and symptoms; * Understand and sign an informed consent form; * Willing and able to make required study visits and follow study instructions, and comply with dosing study medication as instructed; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Contraindications or hypersensitivity to study medications or their components; * Best-corrected visual acuity (BCVA) score worse than 55 ETDRS letters (equivalent to approximately 0.60 logMAR, 20/80 Snellen, or 0.25 decimal) in either eye; * Any ocular condition that could affect the study outcomes; * Presumed or actual ocular infection or history of ocular herpes in either eye; * Known history of retinal detachment, diabetic retinopathy, or any progressive retinal disease; * Willing and able to avoid the use of any other topical ocular medication(s) (including artificial tear products); * Any significant illness that could be expected to interfere with the study, particularly any autoimmune disease; * Intraocular surgery in either eye within 6 months, or ocular laser surgery in either eye within 3 months, or anticipation of ocular surgery during the study; ocular trauma in either eye within 3 months of baseline visit; * Clinically relevant recent (within 6 months of baseline visit) history of or current severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, autoimmune disease and other relevant systemic diseases that would preclude the safe administration of a topical antihistamine/mast cell stabilizer in the opinion of the Investigator; * Use of systemic medication(s) on a chronic dosing regimen for less than 1 month or have changed dosage within the month prior to baseline visit; * Use of any disallowed medication (topical, topical ophthalmic, systemic and/or injectable) during the period indicated prior to baseline visit. These medications are also not allowed during the study. Disallowed medications include all anti-allergy therapies including those contained in prescription or over-the-counter sleeping aids; * Use of cold compresses on the eyes during the course of the study; * Cannot be dosed in both eyes; * Cannot avoid contact lens wear during the course of the study; * Therapy with another investigational agent within 30 days of baseline visit, or during the study; * Women of childbearing potential who are pregnant, intend to become pregnant during the study period, breast-feeding, or not using adequate birth control methods; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14 | Baseline, Day 14 | Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis. |
Participant flow
Recruitment details
Participants were recruited from 10 study centers located in China.
Pre-assignment details
Of the 383 enrolled, 130 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (253).
Participants by arm
| Arm | Count |
|---|---|
| PATADAY Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days | 123 |
| PATANOL Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days | 122 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | PATADAY | PATANOL | Total |
|---|---|---|---|
| Age, Continuous | 32.5 years STANDARD_DEVIATION 13.72 | 31.9 years STANDARD_DEVIATION 12.79 | 32.2 years STANDARD_DEVIATION 13.24 |
| Itching Score | 3.35 units on a scale STANDARD_DEVIATION 0.377 | 3.43 units on a scale STANDARD_DEVIATION 0.373 | 3.39 units on a scale STANDARD_DEVIATION 0.376 |
| Sex: Female, Male Female | 81 Participants | 86 Participants | 167 Participants |
| Sex: Female, Male Male | 42 Participants | 36 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 383 | 0 / 126 | 0 / 126 |
| serious Total, serious adverse events | 0 / 383 | 0 / 126 | 0 / 126 |
Outcome results
Primary
Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14
Severity of ocular itching was evaluated as the worst score observed in the past 24 hours prior to each study visit. Ocular itching was assessed by the participant on a scale from 0-4, where 0=None and 4=Incapacitating itch. One eye (study eye) contributed to the analysis.
Time frame: Baseline, Day 14
Population: Per Protocol Set with non-missing data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PATADAY | Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14 | -2.57 units on a scale | Standard Error 0.09 |
| PATANOL | Change From Baseline in Worst Ocular Itching Score During the 24 Hours Prior at Day 14 | -2.62 units on a scale | Standard Error 0.092 |