Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers

A Multi-center, Double-masked, Randomized, Placebo-controlled, Parallel-group Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy, Normal Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: KetoNaph; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 534
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With at Least One Adverse Event.	An adverse event was defined as unfavorable and unintended sign, symptom, or disease temporally associated with the use of a test article, whether or not considered related to test article.	42 days

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Principal Investigator: Tuyen Ong, MD, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: July 6, 2010
• First Submitted That Met QC Criteria: July 7, 2010
• First Posted (Estimate): July 9, 2010

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: 586