Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.
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|ClinicalTrials.gov Identifier: NCT00769886|
Recruitment Status : Completed
First Posted : October 9, 2008
Last Update Posted : December 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Allergic Conjunctivitis||Drug: Ketotifen/naphazoline Drug: Ketotifen Drug: Naphazoline Drug: Vehicle||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multi-Center, Double-Masked, Randomized, Vehicle and Active Controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||June 2009|
KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution
One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.
Active Comparator: Naphazoline
Naphazoline HCl 0.05% ophthalmic solution
One drop of naphazoline in study eye at vist 3 and visit 4.
Active Comparator: Ketotifen
Ketotifen fumarate 0.025% ophthalmic solution
One drop of Ketotifen in study eye at visit 3 and visit 4.
Placebo Comparator: Vehicle
Vehicle of KetoNaph ophthalmic solution
One drop of vehicle in study eye at visit 3 and visit 4.
- Ocular itching [ Time Frame: 3, 5 and 7 minutes post-challenge ]
- Conjunctival redness [ Time Frame: 7, 15 and 20 minutes post-challenge ]
- Ciliary and episcleral redness, chemosis, lid swelling, tearing, ocular mucus drainage [ Time Frame: 7, 15 and 20 minutes post challenge ]
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): NCT00769886
|United States, Massachusetts|
|Ophthalmic Research Consultants, Inc.|
|North Andover, Massachusetts, United States, 01845|