Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Olopatadine hydrochloride ophthalmic solution, 0.7%, Olopatadine Hydrochloride Nasal Spray 0.6%, Olopatadine 0.6%, Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, Olopatadine, 0.2%, Olopatadine hydrochloride ophthalmic solution, 0.2%, Olopatadine 0.6% nasal spray, Olopatadine Hydrochloride Ophthalmic Solution 0.2%
Olopatadine, 0.7% · 8 trials · 4 indications
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.
Ocular itching will be assessed by the subject and graded on a 6-point scale, where 0=did not occur and 5=virtually all the time over the past 3 days.
Ocular hyperemia (redness) will be assessed by the investigator. Total hyperemia score is defined as the sum of the palpebral and bulbar conjunctival scores.
Total Nasal Symptom Score comprised of scoring each of the following symptoms: runny nose, stuffy nose, itchy nose, and sneezing. Each symptom was scored as a 0 (none), 1 (mild), 2 (moderate), or 3 (severe). The 4 individual symptom scores were then added together for a total nasal symptom score. The percent change from baseline was defined as the average of the morning and evening severity scores for the sum of the assessments of the 4 individual scores averaged across all days.
Mean Patient-Rated Relief Assessment at Day 30. The patient-rated relief assessment (PRRA) was a 4-point scale with 1=Complete Relief; 2=Moderate Relief; 3=Mild Relief; and 4=No Relief.
The appearance in a participant of any of the following from Baseline: anatomic abnormalities, evidence of infection, bleeding, and/or ulcerations of the mucosa
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.
| Arm | Type | Description |
|---|---|---|
| PATADAY | EXPERIMENTAL | 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 |
| PATANOL | ACTIVE_COMPARATOR | Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days |
| AL-4943A | EXPERIMENTAL | Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, 2 drops instilled in each eye twice daily for 10 weeks |
| Pataday+Pataday Vehicle | EXPERIMENTAL | Olopatadine Hydrochloride Ophthalmic Solution 0.2%, 1 drop in 1 eye and Olopatadine 0.2% Vehicle in the contralateral eye |
| Patanol+Patanol Vehicle | ACTIVE_COMPARATOR | Olopatadine Hydrochloride Ophthalmic Solution, 0.1%, 1 drop in 1 eye and Olopatadine 0.1% Vehicle in the contralateral eye |
| Olopatadine 0.6% 1 Spray | EXPERIMENTAL | Olopatadine HCl 0.6% 1 spray per nostril twice daily |
| Vehicle 1 spray | PLACEBO_COMPARATOR | Vehicle 1 spray per nostril twice daily |
| Olopatadine 0.6% 2 sprays | EXPERIMENTAL | Olopatadine HCl 0.6% 2 sprays per nostril twice daily |
| Vehicle 2 sprays | PLACEBO_COMPARATOR | Vehicle 2 sprays per nostril twice daily |
| Olopatadine 0.6% Nasal Spray | EXPERIMENTAL | 2 sprays each nostril twice daily |
| Placebo Nasal Spray | PLACEBO_COMPARATOR | 2 sprays each nostril twice daily |
| Olopatadine Hydrochloride 0.2% | EXPERIMENTAL | Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop in each eye, once-daily in the morning for 6 weeks |
| Vehicle | PLACEBO_COMPARATOR | Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop in each eye, once-daily in the morning for 6 weeks |
| 1 | EXPERIMENTAL | Olopatadine Hydrochloride Nasal Spray 0.6% |
| 2 | PLACEBO_COMPARATOR | Olopatadine Hydrochloride Nasal Spray Vehicle |
| 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 |
| 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 |
|---|---|---|
| Olopatadine Hydrochloride Ophthalmic Solution 0.2% | DRUG | - |
| Olopatadine Hydrochloride Ophthalmic Solution 0.1% | DRUG | - |
| Olopatadine 0.2% Vehicle | DRUG | Inactive ingredients used as placebo comparator |
| Olopatadine Hydrochloride Ophthalmic Solution, 0.2% | DRUG | - |
| Olopatadine Hydrochloride Ophthalmic Solution, 0.1% | DRUG | - |
| Olopatadine 0.1% Vehicle | DRUG | Inactive ingredients used as placebo comparator |
| Olopatadine Hydrochloride Nasal Spray 0.6% | DRUG | Olopatadine HCl 1 or 2 sprays per nostril twice daily |
| Vehicle | DRUG | Vehicle 1 or 2 sprays per nostril twice daily |
| Olopatadine 0.6% nasal spray | DRUG | 2 sprays each nostril twice daily |
| Placebo Nasal Spray | DRUG | 2 sprays each nostril twice daily |
| Olopatadine Hydrochloride Ophthalmic Solution Vehicle | DRUG | Inactive ingredients used as a placebo comparator |
| Olopatadine Hydrochloride Nasal Spray Vehicle | DRUG | one spray in each nostril twice daily for 2 weeks |
| Olopatadine hydrochloride ophthalmic solution, 0.7% | DRUG | Treatment A |
| Ketotifen fumarate ophthalmic solution, 0.025% | DRUG | Treatment C |
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 an...
Olopatadine 0.2% is used for allergic rhinitis, seasonal allergic rhinitis, perennial allergic rhinitis, and allergic conjunctivitis. It is an ophthalmic small molecule being developed by Alcon Inc. for these allergic conditions.
Olopatadine 0.2% is developed by Alcon Inc., a company traded under the ticker ALC. Alcon is conducting clinical trials to evaluate the safety and efficacy of this drug for allergic rhinitis and allergic conjunctivitis.
Olopatadine 0.2% is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 3 trials are completed and include studies for perennial allergic rhinitis, seasonal allergic rhinitis, and allergic conjunctivitis.
Olopatadine 0.2% has completed several clinical trials, including NCT00578331 for perennial allergic rhinitis, NCT00578929 for seasonal allergic rhinitis, and NCT02322216 for allergic conjunctivitis. These trials enrolled a total of 2,388 participants across the United States and other regions.
Olopatadine 0.2% is related to Patanase, as both contain olopatadine. However, Olopatadine 0.2% is an ophthalmic solution, while Patanase is a nasal spray. They are used for different routes of administration in treating allergic conditions.