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Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01258309
First Posted: December 10, 2010
Last Update Posted: January 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
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.

Condition Intervention Phase
Rhinitis, Allergic, Seasonal Conjunctivitis, Allergic Drug: olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution Drug: olopatadine hydrochloride 0.1% ophthalmic solution Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Ocular Itching [ Time Frame: Day 21 ]

Secondary Outcome Measures:
  • Hyperemia [ Time Frame: Day 21 ]
  • Chemosis [ Time Frame: Day 21 ]
  • Ocular mucous discharge [ Time Frame: Day 21 ]

Enrollment: 129
Study Start Date: December 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution
Drug: olopatadine 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.
Active Comparator: 2
olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution
Drug: olopatadine hydrochloride 0.1% ophthalmic solution
One drop of olopatadine hydrochloride 0.1% ophthalmic solution administered to each eye, twice daily for 21 days.
Other Name: Patanol®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258309


Locations
India
Bangalore, Karnataka, India
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01258309     History of Changes
Other Study ID Numbers: Olo-keto/2009
First Submitted: December 9, 2010
First Posted: December 10, 2010
Last Update Posted: January 25, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Rhinitis
Conjunctivitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Ketorolac
Ketorolac Tromethamine
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors