Allergic Conjunctivitis
Conditions
Keywords
allergic conjunctivitis, Pataday, Olopatadine
Brief summary
The purpose of this study is to descriptively evaluate the corneal structures of allergic conjunctivitis patients.
Detailed description
Heidelberg Retina Tomograph (HRT) will be used to descriptively evaluate the corneal structures and assess the immune cell status of allergic conjunctivitis patients pre- and post-treatment with olopatadine 0.2% in relation to a normative database.
Interventions
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Read, sign, and date an Ethics Committee reviewed and approved informed consent form. * Females of childbearing potential who: * Are not breast-feeding; * Do not intend to become pregnant for the duration of the study; * Are using adequate birth control methods and agree to continue for the duration of the study. * Able to read, understand and answer questions by investigator. * Willing and able to attend all required study visits and follow directions as stipulated by the protocol and investigator. * History of allergic conjunctivitis (within the past 12 months) and active signs and symptoms of ocular allergies for which treatment is necessary, in the opinion of the investigator. * Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with or without glasses correction. * Ocular health within normal limits as determined by the investigator. * No contact lens wear 14 days prior to enrollment and willing to not wear contact lenses for the duration of the study. * Willing to follow a 14-day washout period due to contraindicated medication use, if deemed necessary by investigator. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Contraindications or hypersensitivity to the use of the test article or its components. * Inability or unwillingness to follow all study instructions and complete study visits as required. * Only one sighted eye or visual acuity not correctable to 20/30 (Snellen) in both eyes at the Screening Visit. * Ocular trauma within 6 months prior to Visit 1 in either eye. * Any ocular surgical intervention within six months prior to Visit 1 or anticipation of ocular surgery during the study. * Presumed or actual ocular infection within 30 days prior to Visit 1. * Any severe or serious ocular condition or significant illness. * Any abnormal slit-lamp findings at the time of the Screening Visit. * Contact lens wear within 14 days prior to the study start and unwillingness to undergo a wash-out period of 14 days; unwilling to not wear contact lenses for the duration of the study. * Use of over-the-counter (OTC) ocular medications within the past 14 days unless willing to follow wash out period. * Use of topical or systemic ocular medications requiring longer than a two-week washout period. * Participation in any other investigational study in the 30-day period before entry into this study (i.e., Visit 1) or concomitantly with this study. * Women who are pregnant, nursing, or of childbearing potential not utilizing adequate birth control measures. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Assessed Ocular Itching | Baseline (Day 1), Day 14 | The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from 1 study center located in the United States.
Pre-assignment details
Of the 17 participants enrolled, 4 were exited from the study as screen failures prior to exposure to the test product. This reporting group includes all participants exposed to the test product (13).
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not meet inc/exc criteria | 3 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 37.0 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Patient-Assessed Ocular Itching
The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.
Time frame: Baseline (Day 1), Day 14
Population: The analysis population includes all participants exposed to the test product. Here, n is the number of participants with non-missing values at the specific time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Left Eye | Patient-Assessed Ocular Itching | Baseline (Day 1) | 2.2 units on a scale | Standard Deviation 0.85 |
| Left Eye | Patient-Assessed Ocular Itching | Day 14 (n=11) | 0.5 units on a scale | Standard Deviation 0.52 |
| Right Eye | Patient-Assessed Ocular Itching | Baseline (Day 1) | 2.2 units on a scale | Standard Deviation 0.92 |
| Right Eye | Patient-Assessed Ocular Itching | Day 14 (n=11) | 0.5 units on a scale | Standard Deviation 0.52 |