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

NCT01119287 | Completed Phase 4 Results

• 1 other identifier: C-10-002
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Allergic Conjunctivitis

Keywords

Conjunctivitis; ocular allergy

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Baseline (Visit 3, pre-treatment); Visit 6 (Day 9 of treatment)

• Mean Change From Baseline Patient-Assessed Ocular Itching, Area Under the Curve From Time Zero to Hour 3 [AUC (0-3)], Patanol and Placebo

  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.

  Baseline (Visit 2, pre-treatment), Visit 5 (Day 8 of treatment)

Study Arms (3)

Maxidex

EXPERIMENTAL

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

Patanol

EXPERIMENTAL

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

Tears Naturale II

PLACEBO COMPARATOR

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

Interventions

Dexamethasone 0.1% ophthalmic suspension DRUG

Maxidex

Maxidex

Olopatadine hydrochloride 0.1% ophthalmic solution DRUG

Patanol

Patanol

Inactive ingredients, used as placebo OTHER

Tears Naturale II

Tears Naturale II

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center For Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic; Conjunctivitis

Interventions

Dexamethasone; Olopatadine Hydrochloride; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Head, Alcon Clinical
• Organization: Alcon Research

1-888-451-3937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 7, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 28, 2014
• Results First Posted: March 6, 2013

Record last verified: 2013-03

Locations

US (1)