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

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ClinicalTrials.gov Identifier: NCT01470118
Recruitment Status : Completed
First Posted : November 11, 2011
Results First Posted : February 21, 2013
Last Update Posted : February 21, 2013
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Conjunctivitis, Allergic Drug: alcaftadine 0.25% ophthalmic solution Drug: olopatadine 0.2% ophthalmic solution Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye

Arm Intervention/treatment
Active Comparator: LASTACAFT® (alcaftadine 0.25%)
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
Drug: alcaftadine 0.25% ophthalmic solution
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
Other Name: LASTACAFT®

Active Comparator: Pataday™ (olopatadine 0.2%)
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
Drug: olopatadine 0.2% ophthalmic solution
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
Other Name: Pataday™

Placebo Comparator: Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)
One drop of placebo instilled in each eye at Day 0 and Day 14.
Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
One drop of placebo instilled in each eye at Day 0 and Day 14.
Other Name: Tears Naturale® II Artificial Tears




Primary Outcome Measures :
  1. Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 [ Time Frame: Day 0 Hour 16 ]
    Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.

  2. Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24 [ Time Frame: Day 14 Hour 24 ]
    Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.


Secondary Outcome Measures :
  1. Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 [ Time Frame: Day 14 Hour 24 ]
    Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness.

  2. Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 [ Time Frame: Day 14 Hour 24 ]
    Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness.

  3. Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 [ Time Frame: Day 14 Hour 24 ]
    Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness.

  4. Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 [ Time Frame: Day 14 Hour 24 ]
    Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis.

  5. Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 [ Time Frame: Day 14 Hour 24 ]
    Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling.

  6. Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24 [ Time Frame: Day 14 Hour 24 ]
    Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored 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 was averaged (i.e., one score per subject). A lower score was indicative of less tearing.



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01470118


Locations
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United States, Pennsylvania
Philadelphia, Pennsylvania, United States
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01470118     History of Changes
Other Study ID Numbers: GMA-LAS-011-001
First Posted: November 11, 2011    Key Record Dates
Results First Posted: February 21, 2013
Last Update Posted: February 21, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Olopatadine Hydrochloride
Dextrans
Ophthalmic Solutions
Pharmaceutical Solutions
Alcaftadine
Anticoagulants
Plasma Substitutes
Blood Substitutes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action