A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis

Conjunctivitis, Allergic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01732757
• Other study ID #: GMA-LAS-12-023
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2012
• Last updated: November 27, 2013
• Start date: November 2012
• Est. completion date: December 2012

Study information

• Verified date: November 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular itching associated with allergic conjunctivitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• History of ocular allergies within the past 24 months.

• Able to avoid wearing contact lenses for at least 72 hours prior to and during the study trial period.

Exclusion Criteria:

• Any presence of active ocular infection or history of an ocular herpetic infection.

• Ocular surgery within 3 months prior to the first visit or refractive surgery within the past 6 months.

• Have any planned surgery during the study or 30 days after the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Alcaftadine 0.25%
One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
• Olopatadine 0.2%
One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
• dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
One drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0	Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.	Day 0 at 3 Minutes Post Challenge	No
Secondary	Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0	Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.	Day 0	No
Secondary	Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0	Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score <1.	Day 0	No
Secondary	Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0	Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.	Day 0	No
Secondary	Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0	Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).	Day 0	No
Secondary	Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0	The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.	Day 0	No
Secondary	Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0	Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.	Day 0	No
Secondary	Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0	The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.	Day 0	No
Secondary	Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0	Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.	Day 0	No
Secondary	Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0	Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.	Day 0	No
Secondary	Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0	Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less tearing.	Day 0	No