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The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.
In this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. Following instillation of study medication, subjects will complete a 3-minute discomfort profile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Olopatadine, 0.7% | Experimental | Olopatadine hydrochloride ophthalmic solution, 0.7%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic vehicle and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized |
|
| Vehicle | Placebo Comparator | Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized |
|
| Zaditor | Active Comparator | Ketotifen fumarate ophthalmic solution, 0.025%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and olopatadine hydrochloride ophthalmic solution vehicle, Periods 2 and 3, as randomized |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olopatadine hydrochloride ophthalmic solution, 0.7% | Drug | Treatment A |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak discomfort score over a 3-minute period after drop instillation | Ocular discomfort as measured by Visual Analog Scale (VAS) with 0=none to 50=severe, was assessed by subjects every 30 seconds between 0 to 180 seconds after drop instillation (at 0, 30, 60, 90, 120, 150, and 180 seconds). Peak discomfort (maximum observed VAS discomfort score over the 3-minute period) for each subject in each period was analyzed. | Up to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular Symptoms | Ocular symptoms (burning, stinging, tearing, blurring, and stickiness) assessed by the subject after instillation of drop as a single score where 0=none to 9=severe. | Up to Day 3 |
| Product Acceptability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Abhijit Narvekar, MS, MBBS | Alcon Research | Study Director |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| ID | Term |
|---|---|
| D000069605 | Olopatadine Hydrochloride |
| C514418 | ketotifen fumarate ophthalmic solution |
| ID | Term |
|---|---|
| D003990 | Dibenzoxepins |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Olopatadine hydrochloride ophthalmic solution vehicle | Drug | Treatment B, inactive ingredients used as placebo |
|
| Ketotifen fumarate ophthalmic solution, 0.025% | Drug | Treatment C |
|
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Product Acceptability assessed by the subject after instillation of drop as a single score where 0=very acceptable and 100=not acceptable.
| Up to Day 3 |
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |