Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01159015
Recruitment Status : Completed
First Posted : July 9, 2010
Last Update Posted : December 17, 2013
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: KetoNaph Drug: Vehicle Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Screening
Official Title: A Multi-center, Double-masked, Randomized, Placebo-controlled, Parallel-group Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy, Normal Volunteers
Study Start Date : July 2010
Actual Primary Completion Date : September 2010
Actual Study Completion Date : October 2010

Arm Intervention/treatment
Experimental: KetoNaph
KetoNaph Ophthalmic Solution
Drug: KetoNaph
Ophthalmic Solution administered BID for 6 weeks

Placebo Comparator: Vehicle
Vehicle of KetoNaph Ophthalmic Solution
Drug: Vehicle
Vehicle of KetoNaph ophthalmic solution administered bid for six weeks

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: All visits 1-4; day 0, 7, 21, and 42 ]
    Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a test article, whether or not considered related to test article. Measured as mild moderate or severe

Secondary Outcome Measures :
  1. Biomicroscopy [ Time Frame: All visits 1-4; days 0, 7, 21, and 42 ]
    Measure redness and swelling on a scale of 0-4, none to very severe

  2. Visual Acuity [ Time Frame: Visits 1-4; day 0, 7, 21, 42 ]
    Measures change from baseline

  3. Intraocular pressure [ Time Frame: Visits 1 and 4; Day 0 and 42 ]
    Change from baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects less than 18 years of age, have either a history or family history of ocular allergy.
  • ocular health within normal limits, including a calculated best-corrected visual acuity of 0.3 logMar or better, in each eye. For subjects under 10 years old who are developmentally unable to use the ETDRS chart, visual acuity will be made using the LEA symbols. For these subjects, 20-foot Snellen equivalent units of 20/63 or better in both eyes will be required.

Exclusion Criteria:

  • Contraindications or sensitivities to the use of any of the investigational product(s) or their components.
  • Subjects less than 18 years of age that have had symptoms and/or signs of allergic conjunctivitis/rhinitis and/or treatment with topical or systemic anti-allergy therapy, or have had a history of ragweed hypersensitivity during the 21-day period prior to visit 1.
  • Surgical intervention within three months prior to Visit 1 or during the refractive surgery within the past 6 months.
  • A known history of retinal detachment, diabetic retinopathy, or active retinal disease;
  • An active ocular infection (bacterial, viral or fungal
  • Use of any topical ophthalmic agents other than investigational products during study participation or within 5 days of beginning study treatment.
  • Current or anticipated use of contact lenses during study participation or within 5 days of beginning study treatment.
  • Current, prior (within 14 days of beginning study treatment) or anticipated use of systemic corticosteroids, and/or any other systemic medications which the Investigator feels may confound study data or interfere with the subject's study participation. Prior (within 21 days of beginning study treatment), current or anticipated use of any topical (including nasal) or systemic anti-allergy medications.
  • Intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a normal IOP with a diagnosis of glaucoma.

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 identifier (NCT number): NCT01159015

Sponsors and Collaborators
Bausch & Lomb Incorporated
Principal Investigator: Tuyen Ong, MD Bausch & Lomb Incorporated

Responsible Party: Bausch & Lomb Incorporated Identifier: NCT01159015     History of Changes
Other Study ID Numbers: 586
First Posted: July 9, 2010    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions