Comparison of Tolerability Between Two Allergy Drops

Allergic Conjunctivitis Clinical Trial

Official title:

Comparison of Tolerability Between Two Allergy Drops

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01390961
• Other study ID #: IIT-000256
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: July 7, 2011
• Last updated: July 7, 2011
• Start date: August 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2011
• Source: Hom, Milton M., OD, FAAO
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Comfort is compared between two allergy drops

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 48
• Est. completion date: January 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Months and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• alacaftadine and naphazoline HCl & pheniramine maleate
once a day

Locations

Country	Name	City	State
United States	Milton M. Hom, OD, FAAO.	Azusa	California

Sponsors (2)

Lead Sponsor	Collaborator
Hom, Milton M., OD, FAAO	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability	Tolerability measured by questionnaire Visual Analog scale 1 to 100	8 weeks	No