Assessing the Efficacy of Maxidex® and Patanol® for the Treatment of Allergic Conjunctivitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01119287
First received: May 4, 2010
Last updated: February 27, 2014
Last verified: March 2013
  Purpose

The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels in an Environmental Exposure Chamber (EEC).


Condition Intervention Phase
Allergic Conjunctivitis
Drug: Dexamethasone 0.1% ophthalmic suspension
Drug: Olopatadine hydrochloride 0.1% ophthalmic solution
Other: Inactive ingredients, used as placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: A Randomized, Double-Masked, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of Maxidex® (0.1% Dexamethasone) Ophthalmic Suspension and Patanol® (0.1% Olopatadine Hydrochloride) Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in an Environmental Exposure Chamber (EEC) Model

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Change From Baseline in Staff-Assessed Ocular Redness, Area Under the Curve From Time Zero to Hour 10 [AUC (0-10)], Maxidex and Placebo [ Time Frame: Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment) ] [ Designated as safety issue: No ]
    Ocular redness ratings were collected for nasal and temporal areas of each eye and scored on a scale from 0 (none) to 4 (extremely severe), 0.5 unit steps permitted. The AUC computation was based on peak redness score (maximum of four areas of redness) at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, 3 hours in the EEC and 3.5, 4, 5, 6, 7, 8, 9, 10 hours in the Clinic). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 6). This outcome measure evaluates a late-phase effect, for which Maxidex vs. Placebo is the meaningful comparison.

  • Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo [ Time Frame: Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment) ] [ Designated as safety issue: No ]
    Ocular itching was scored a scale from 0 (none) to 4 (incapacitating itch with irresistible urge to rub) in 0.5 unit steps. The AUC computation was based on the score at each time point (pre-treatment, 0.25, 0.5, 1.0, 1.5, 2.0, 2.5, and 3 hours in the EEC). The patient was dosed AM 30 minutes prior to entering the EEC (Visit 5). This outcome measure evaluates an early-phase effect, for which Patanol vs. Placebo is the meaningful comparison.


Enrollment: 180
Study Start Date: March 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Maxidex
Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
Drug: Dexamethasone 0.1% ophthalmic suspension
Maxidex
Experimental: Patanol
Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
Drug: Olopatadine hydrochloride 0.1% ophthalmic solution
Patanol
Placebo Comparator: Tears Naturale II
Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
Other: Inactive ingredients, used as placebo
Tears Naturale II

Detailed Description:

This study consisted of 6 visits. Visit 1 was the Medical Screening Visit (skin prick test). Visit 2 and Visit 3 consisted of 2 consecutive EEC Visits (3 hours in the EEC followed by 7 hours in the Clinic, 10 hours total, each visit) followed by 7 days of wash-out. Visit 2 and Visit 3 occurred prior to dispense and the measures obtained during these visits were used as baseline. At Visit 4 patients were randomized and dispensed the assigned study medication for 7 days of at-home dosing. Visit 5 (Day 8 of treatment) and Visit 6 (Day 9 of treatment) consisted of 2 additional consecutive EEC Visits (3 hours in the EEC followed by 7 hours in the clinic, 10 hours total, each visit). During each EEC visit, patients were exposed to either ragweed or cat allergen, depending on their skin prick test results. Of the 180 participants enrolled, 170 received at least one dose of study treatment and were randomized to one of the three study treatments.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 1 year history of allergic conjunctivitis.
  • Ability to self administer ophthalmic drops.
  • Ability to avoid use of disallowed medications during the entire study period and specified period prior to visit 1.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Presence of any ocular infection.
  • Confirmed diagnosis of dry eye.
  • Presence of glaucoma or ocular hypertension.
  • Moderate to severe asthma.
  • Any severe, unstable, or uncontrolled systemic disease.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119287

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01119287     History of Changes
Other Study ID Numbers: C-10-002
Study First Received: May 4, 2010
Results First Received: January 28, 2013
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration
Canada: Ethics Review Committee

Keywords provided by Alcon Research:
Conjunctivitis
ocular allergy

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Olopatadine
Ophthalmic Solutions
Pharmaceutical Solutions
Analgesics
Analgesics, Non-Narcotic
Anti-Allergic Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antirheumatic Agents
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Histamine Agents
Histamine Antagonists

ClinicalTrials.gov processed this record on October 23, 2014