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To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olopatadine 0.1% one eye | Experimental | Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye |
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| Tranilast 0.5% one eye | Experimental | Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye |
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| Placebo (Olopatadine) | Placebo Comparator | Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye |
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| Placebo (Tranilast) | Placebo Comparator | Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olopatadine 0.1% | Drug | one drop in one eye |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-180 minutes after entering the examination room |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Total Score in Ocular Symptom Questionnaire | 15-180 min. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
The recruitment period: May 21-31, 2008 Location: Samoncho Clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Olopatadine 0.1% First, Then Tranilast Second | Patients received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye first, then received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye next |
| FG001 | Tranilast 0.5% First, Then Olopatadine Second |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
|
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| Tranilast 0.5% |
| Drug |
one drop in one eye |
|
| Placebo (Olopatadine) | Drug | one drop in contralateral eye |
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| Placebo (Tranilast) | Drug | one drop in contralateral eye |
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Patients received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye first, then received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye last. |
| COMPLETED |
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| NOT COMPLETED |
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| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | Units on a scale | 0-180 minutes after entering the examination room |
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| Secondary | Change in Total Score in Ocular Symptom Questionnaire | Not Posted | 15-180 min. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Olopatadine 0.1% One Eye | Olopatadine 0.1% in one eye in either the first or second period | 0 | 50 | 0 | 50 | ||
| EG001 | Tranilast 0.5% One Eye | Tranilast 0.5% in one eye in either the first or second period | 0 | 50 | 0 | 50 | ||
| EG002 | Placebo (Olopatadine) One Eye | Placebo (Olopatadine) in one eye in either the first or second period | 0 | 50 | 0 | 50 | ||
| EG003 | Placebo (Tranilast) One Eye | Placebo (Tranilast) in one eye in either the first or second period | 0 | 50 | 0 | 50 |
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Technical problems with measurement leading to unreliable or uninterpretable data.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alcon Clinical | Alcon Labs | 888.451.3937; 817.568.6725 | medinfo@alconlabs.com |
| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| C012293 | tranilast |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| 30 minutes |
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| 45 minutes |
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| 60 minutes |
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| 75 minutes |
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| 90 minutes |
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| 105 minutes |
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| 120 minutes |
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| 135 minutes |
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| 150 minutes |
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| 165 minutes |
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| 180 minutes |
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