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NCT01390961 Clinical Trial

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
Secondary ID
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

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
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