Allergic Conjunctivitis
Conditions
Keywords
conjunctivitis
Brief summary
To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.
Interventions
DRUGOlopatadine 0.1%
one drop in one eye
DRUGTranilast 0.5%
one drop in one eye
DRUGPlacebo (Olopatadine)
one drop in contralateral eye
DRUGPlacebo (Tranilast)
one drop in contralateral eye
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age/Gender: males and females aged \>20 to \< 65 years (at the time of obtaining consent). 2. Positive cases in whom blood specific IgE antibody quantification against cedar pollen showed class 2-6 in a health checkup conducted within the past 3 years. 3. Cases who were diagnosed as patients with seasonal allergic conjunctivitis and were judged eligible as subjects of the said study by the investigator or co-investigator from the results of medical examination conducted on the day of the study or prior to it. 4. Cases who gave consent on study participation of their own free will in writing, with understanding the contents of the said study.
Exclusion criteria
1. Cases with an ocular disease that requires treatment other than allergic conjunctivitis. 2. Cases with an inflammatory ocular disease in the external/anterior part of the eye that may affect drug efficacy evaluation. 3. Cases with a respiratory disease such as bronchial asthma other than allergic rhinitis. 4. Cases with past history of anaphylaxis. 5. Cases with past history of hypersensitivity to olopatadine hydrochloride/tranilast. 6. Cases undergoing immunotherapy (hyposensitization therapy; modulated therapy). 7. Patients who are pregnant, lactating women, or may be pregnant, or cases wishing to be pregnant during the study period. 8. Other cases who are judged ineligible for participation in the main study by the doctor in charge of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 0-180 minutes after entering the examination room | Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching. |
Secondary
| Measure | Time frame |
|---|---|
| Change in Total Score in Ocular Symptom Questionnaire | 15-180 min. |
Participant flow
Recruitment details
The recruitment period: May 21-31, 2008 Location: Samoncho Clinic
Pre-assignment details
The study was conducted using an Ohio chamber in two parts: 1) a proof-of concept pilot study designed to assess the appropriateness of the OHIO chamber to induce ocular symptoms. 2) a randomized, single-masked, placebo-controlled, cross-over study.
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 15 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 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 | 0 / 50 | 0 / 50 |
Outcome results
Primary
Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire
Ocular itching score was assessed using a 5 point scale, with 1 meaning no itching and 4 meaning worst itching.
Time frame: 0-180 minutes after entering the examination room
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Olopatadine 0.1% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 105 minutes | 0.94 Units on a scale | Standard Deviation 0.58 |
| Olopatadine 0.1% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 90 minutes | 0.92 Units on a scale | Standard Deviation 0.81 |
| Olopatadine 0.1% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 60 minutes | 0.67 Units on a scale | Standard Deviation 0.76 |
| Olopatadine 0.1% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 165 minutes | 1.28 Units on a scale | Standard Deviation 0.78 |
| Olopatadine 0.1% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 75 minutes | 0.81 Units on a scale | Standard Deviation 0.82 |
| Olopatadine 0.1% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 150 minutes | 1.25 Units on a scale | Standard Deviation 0.77 |
| Olopatadine 0.1% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 30 minutes | 0.44 Units on a scale | Standard Deviation 0.61 |
| Olopatadine 0.1% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 15 minutes | 0.19 Units on a scale | Standard Deviation 0.47 |
| Olopatadine 0.1% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 135 minutes | 1.17 Units on a scale | Standard Deviation 0.7 |
| Olopatadine 0.1% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 120 minutes | 1.03 Units on a scale | Standard Deviation 0.65 |
| Olopatadine 0.1% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 45 minutes | 0.50 Units on a scale | Standard Deviation 0.7 |
| Olopatadine 0.1% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 180 minutes | 1.39 Units on a scale | Standard Deviation 0.77 |
| Tranilast 0.5% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 135 minutes | 1.14 Units on a scale | Standard Deviation 0.72 |
| Tranilast 0.5% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 15 minutes | 0.11 Units on a scale | Standard Deviation 0.46 |
| Tranilast 0.5% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 30 minutes | 0.25 Units on a scale | Standard Deviation 0.5 |
| Tranilast 0.5% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 45 minutes | 0.36 Units on a scale | Standard Deviation 0.68 |
| Tranilast 0.5% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 60 minutes | 0.50 Units on a scale | Standard Deviation 0.74 |
| Tranilast 0.5% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 75 minutes | 0.67 Units on a scale | Standard Deviation 0.79 |
| Tranilast 0.5% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 90 minutes | 0.86 Units on a scale | Standard Deviation 0.72 |
| Tranilast 0.5% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 105 minutes | 0.86 Units on a scale | Standard Deviation 0.72 |
| Tranilast 0.5% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 120 minutes | 1.03 Units on a scale | Standard Deviation 0.7 |
| Tranilast 0.5% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 150 minutes | 1.14 Units on a scale | Standard Deviation 0.76 |
| Tranilast 0.5% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 165 minutes | 1.14 Units on a scale | Standard Deviation 0.76 |
| Tranilast 0.5% One Eye | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 180 minutes | 1.39 Units on a scale | Standard Deviation 0.77 |
| Placebo (Olopatadine) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 165 minutes | 1.39 Units on a scale | Standard Deviation 0.64 |
| Placebo (Olopatadine) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 45 minutes | 0.50 Units on a scale | Standard Deviation 0.65 |
| Placebo (Olopatadine) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 105 minutes | 1.03 Units on a scale | Standard Deviation 0.7 |
| Placebo (Olopatadine) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 150 minutes | 1.36 Units on a scale | Standard Deviation 0.64 |
| Placebo (Olopatadine) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 120 minutes | 1.19 Units on a scale | Standard Deviation 0.67 |
| Placebo (Olopatadine) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 30 minutes | 0.33 Units on a scale | Standard Deviation 0.53 |
| Placebo (Olopatadine) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 135 minutes | 1.33 Units on a scale | Standard Deviation 0.72 |
| Placebo (Olopatadine) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 15 minutes | 0.06 Units on a scale | Standard Deviation 0.33 |
| Placebo (Olopatadine) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 60 minutes | 0.75 Units on a scale | Standard Deviation 0.69 |
| Placebo (Olopatadine) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 180 minutes | 1.44 Units on a scale | Standard Deviation 0.69 |
| Placebo (Olopatadine) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 75 minutes | 0.92 Units on a scale | Standard Deviation 0.81 |
| Placebo (Olopatadine) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 90 minutes | 0.92 Units on a scale | Standard Deviation 0.69 |
| Placebo (Tranilast) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 45 minutes | 0.56 Units on a scale | Standard Deviation 0.69 |
| Placebo (Tranilast) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 90 minutes | 0.94 Units on a scale | Standard Deviation 0.75 |
| Placebo (Tranilast) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 135 minutes | 1.19 Units on a scale | Standard Deviation 0.82 |
| Placebo (Tranilast) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 165 minutes | 1.33 Units on a scale | Standard Deviation 0.76 |
| Placebo (Tranilast) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 15 minutes | 0.08 Units on a scale | Standard Deviation 0.44 |
| Placebo (Tranilast) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 105 minutes | 0.97 Units on a scale | Standard Deviation 0.81 |
| Placebo (Tranilast) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 30 minutes | 0.28 Units on a scale | Standard Deviation 0.51 |
| Placebo (Tranilast) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 150 minutes | 1.25 Units on a scale | Standard Deviation 0.77 |
| Placebo (Tranilast) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 75 minutes | 0.78 Units on a scale | Standard Deviation 0.76 |
| Placebo (Tranilast) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 120 minutes | 1.08 Units on a scale | Standard Deviation 0.81 |
| Placebo (Tranilast) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 60 minutes | 0.61 Units on a scale | Standard Deviation 0.73 |
| Placebo (Tranilast) | Change in Ocular Itching Score (5-point Scale) in Subjective Symptom Questionnaire | 180 minutes | 1.47 Units on a scale | Standard Deviation 0.88 |
Secondary
Change in Total Score in Ocular Symptom Questionnaire
Time frame: 15-180 min.