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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:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01258309
First received: December 9, 2010
Last updated: January 24, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever Pinkeye
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Ocular Itching [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hyperemia [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Chemosis [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Ocular mucous discharge [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258309

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

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01258309     History of Changes
Other Study ID Numbers: Olo-keto/2009
Study First Received: December 9, 2010
Last Updated: January 24, 2012
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Rhinitis, Allergic, Seasonal
Rhinitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Ketorolac Tromethamine
 Ketorolac
Olopatadine
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 16, 2013