Phase 4 N=13 Randomized Double-blind Diagnostic

Assessment of Alcon's Ocular Image Quantification System

Allergic Conjunctivitis

Bottom Line

View on ClinicalTrials.gov: NCT01282138 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2012

Primary outcome: Primary: Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours — -1.63; -1.11 Units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol) (Drug); Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II) (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Mar 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Patient-Assessed Ocular Itching, Environmental Exposure Chamber (EEC), at 3 Hours	-1.63; -1.11	—
PRIMARY Change From Baseline in Patient-Assessed Ocular Itching, Conjunctival Allergen Provocation Test (CAPT), at 3 Hours	-0.38; -1.15	—

Summary

The purpose of this study was to evaluate ocular responses with different allergen provocation methods.

Eligibility Criteria

Inclusion Criteria

History of allergic conjunctivitis;
Active signs and symptoms of ocular allergies;
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

History of dry eye;
Presence of ocular infection;
Presence of severe or serious ocular conditions;
Symptoms of allergic conjunctivitis;
Use of topical or systemic ocular medications as specified in protocol;
Ocular surgery or laser surgery within 6 months of study start;
Unwilling to discontinue contact lens wear 72 hours prior to Visit 1 and during study period;
Other protocol-defined exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01282138). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.