Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic
Conditions
Brief summary
This study will investigate the safety and efficacy of olopatadine hydrochloride / ketorolac tromethamine fixed dose combination ophthalmic solution compared with olopatadine hydrochloride ophthalmic solution in patients with seasonal allergic conjunctivitis.
Interventions
DRUGolopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution
One drop of olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution administered to each eye, twice daily for 21 days.
One drop of olopatadine hydrochloride 0.1% ophthalmic solution administered to each eye, twice daily for 21 days.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of seasonal allergic conjunctivitis
Exclusion criteria
* Ocular infection or history of ocular herpes infection * History of retinal detachment or diabetic retinopathy * Prior or current use of systemic or topical steroids, NSAIDs, anticholinergics, immunosuppressants, or antihistamines * Ocular surgery within 8 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular Itching | Day 21 |
Secondary
| Measure | Time frame |
|---|---|
| Hyperemia | Day 21 |
| Chemosis | Day 21 |
| Ocular mucous discharge | Day 21 |
Countries
India
Outcome results
None listed