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Completed

NCT Number: NCT00770133

Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.

The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.

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Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ophthalmic Research Consultants, Inc.

North Andover, Massachusetts, 01845, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
  • Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
  • Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
  • Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.

Exclusion criteria

  • Known contraindications or sensitivities to the study medication or its components.
  • Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
  • Use of disallowed medications during the period indicated prior to study enrollment or during the study.

Treatment and study plan

Ketotifen/naphazoline

Drug

One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.

naphazoline

Drug

One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.

Ketotifen

Drug

One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.

Vehicle

Drug

One drop of vehicle ophthalmic solution at visit 3 and visit 4.

Primary outcomes

  1. Ocular Itching

    Time frame: 3, 5, and 7 minutes post challenge at 14 days

    Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0=None and 4.0=Incapacitating itch with an irresistible urge to rub

  2. Conjunctival Redness

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

    Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.

Secondary outcomes

  1. Ciliary Redness

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

    Ciliary hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.

  2. Episcleral Redness

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

    Episcleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.

  3. Chemosis

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

    Chemosis was evaluated by the Investigator at 7, 15, and 20 minutes post challenge on a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.

  4. Eyelid Swelling

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

    Lid swelling was evaluated by the participant at 7, 15, and 20 minutes post challenge on a 0-3 numerical analog scale, with 0.5-unit increments disallowed, where: 0.0=None and 3.0=Severe.

  5. Percentage of Eyes With hTearing

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

    Tearing was evaluated by the participant at 7, 15, and 20 minutes post challenge. Tearing was recorded as either absent or present.

  6. Percentage of Eyes With Ocular Mucus Discharge

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

    Ocular mucous discharge was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Mucous discharged was recorded as either absent or present.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

A Multi-center, Double-masked, Randomized, Placebo-controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis.

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 9, 2008
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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