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, 0.7% is an ophthalmic solution developed for allergic conjunctivitis, and olopatadine formulations are also studied for allergic rhinitis, perennial allergic rhinitis, and seasonal allergic rhinitis. It is a small molecule therapy in the ophthalmology therapeutic area. Alcon Inc. is the developer.
Olopatadine, 0.7% works as an antagonist at the HRH1 target, the histamine H1 receptor. By blocking HRH1, it interferes with histamine-mediated allergic responses. This mechanism underlies its development for allergic conjunctivitis and allergic rhinitis indications.
Olopatadine, 0.7% is developed by Alcon Inc., which trades under the ticker ALC. Alcon is the sponsor behind the clinical program for this ophthalmic solution and related olopatadine formulations.
Olopatadine, 0.7% is in Phase 3 clinical development. It is an investigational small molecule and is not described as approved. The program includes completed Phase 3 and Phase 1 trials, with no active trials currently listed.
Olopatadine, 0.7% has been studied in completed trials including NCT02322216 in Chinese subjects with allergic conjunctivitis, NCT01037179, a long-term open-label study in Japan, and NCT00987272, which used the conjunctival allergen challenge model in Japanese subjects. A Phase 1 safety and comfort study, NCT01326858, was also completed.
Yes. Olopatadine, 0.7% is also known as olopatadine hydrochloride ophthalmic solution, 0.7%. Related names include olopatadine hydrochloride nasal spray 0.6%, olopatadine 0.6%, olopatadine hydrochloride ophthalmic solution 0.2%, and olopatadine 0.2%, reflecting different strengths and formulations.