Comparison of Tolerability Between Two Allergy Drops

• Sponsor: Hom, Milton M., OD, FAAO (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01390961
• Collaborator: Allergan (Industry)
• Enrollment: 48
• Location: 1
• Duration (Months): 5
• Patients Per Site Per Month: 9.5

Study Details

Study Description

Brief Summary

Comfort is compared between two allergy drops

Condition or Disease	Intervention/Treatment	Phase
Allergic Conjunctivitis	Drug: alacaftadine and naphazoline HCl & pheniramine maleate	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Tolerability Between Two Allergy Drops
• Study Start Date: Aug 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2011
• Anticipated Study Completion Date: Jan 1, 2012

Outcome Measures

Primary Outcome Measures

1. Tolerability [8 weeks]

   Tolerability measured by questionnaire Visual Analog scale 1 to 100

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Between the ages of 18 and over inclusive.

• Males or females

• Patient is in generally good & stable overall health.

• Patient likely to comply with study guidelines & study visits.

• Informed consent signed.

• History of allergic conjunctivitis

• Current symptoms of allergic conjunctivitis assessed by the investigator

Exclusion Criteria:

• Corneal refractive surgery or contact lens wear within 6 months of this study.

• Current use of Restasis

• Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.

• Pregnant or lactating women.

• Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Milton M. Hom, OD, FAAO.	Azusa	California	United States	91702

Sponsors and Collaborators

• Hom, Milton M., OD, FAAO
• Allergan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01390961
• Other Study ID Numbers: IIT-000256
• First Posted: Jul 11, 2011
• Last Update Posted: Jul 11, 2011
• Last Verified: Jul 1, 2011

• Keywords provided by , ,: Allergic conjunctivitis
• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Pheniramine; Naphazoline

Study Results

No Results Posted as of Jul 11, 2011