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Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01159015
First received: July 6, 2010
Last updated: October 6, 2011
Last verified: October 2011
History of Changes
  Purpose

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 Intervention Phase
Allergic Conjunctivitis
 Drug: KetoNaph
Drug: Vehicle
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: All visits 1-4; day 0, 7, 21, and 42 ] [ Designated as safety issue: Yes ]
    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:
  • Biomicroscopy [ Time Frame: All visits 1-4; days 0, 7, 21, and 42 ] [ Designated as safety issue: No ]
    Measure redness and swelling on a scale of 0-4, none to very severe

  • Visual Acuity [ Time Frame: Visits 1-4; day 0, 7, 21, 42 ] [ Designated as safety issue: No ]
    Measures change from baseline

  • Intraocular pressure [ Time Frame: Visits 1 and 4; Day 0 and 42 ] [ Designated as safety issue: No ]
    Change from baseline


Enrollment: 501
Study Start Date: July 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159015

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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01159015     History of Changes
Other Study ID Numbers: 586
Study First Received: July 6, 2010
Last Updated: October 6, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on June 13, 2013