A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis

Allergan

Status and phase: Completed; Phase 4

Conditions: Conjunctivitis, Allergic

Treatments: Drug: olopatadine 0.2% ophthalmic solution; Drug: alcaftadine 0.25% ophthalmic solution; Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01470118

GMA-LAS-011-001

Details and patient eligibility

About

This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (placebo) in the prevention of ocular itching associated with allergic conjunctivitis.

Enrollment: 127 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of eye allergies within the past 24 months
• Willing to not wear contact lenses at least 72 hours prior to the study start and during the study period

Exclusion criteria

• Current eye infection
• Eye surgery within 3 months or vision correction surgery within 6 months
• Any planned surgery during the study or 30 days after the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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127 participants in 3 patient groups, including a placebo group

LASTACAFT® (alcaftadine 0.25%)

Active Comparator group

Description:

One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.

Treatment:

Drug: alcaftadine 0.25% ophthalmic solution

Pataday™ (olopatadine 0.2%)

Active Comparator group

Description:

One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.

Treatment:

Drug: olopatadine 0.2% ophthalmic solution

Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)

Placebo Comparator group

Description:

One drop of placebo instilled in each eye at Day 0 and Day 14.

Treatment:

Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%