Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers

NCT ID: NCT01159015

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 534 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2010-10-31

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.

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: TRIPLE

Study Groups

KetoNaph

KetoNaph Ophthalmic Solution

Group Type: EXPERIMENTAL

KetoNaph

Intervention Type: DRUG

Ophthalmic Solution administered BID for 6 weeks

Vehicle

Vehicle of KetoNaph Ophthalmic Solution

Group Type: PLACEBO_COMPARATOR

Vehicle

Intervention Type: DRUG

Vehicle of KetoNaph ophthalmic solution administered bid for six weeks

Interventions

KetoNaph

Ophthalmic Solution administered BID for 6 weeks

Intervention Type: DRUG

Vehicle

Vehicle of KetoNaph ophthalmic solution administered bid for six weeks

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tuyen Ong, MD

Role: PRINCIPAL_INVESTIGATOR

Bausch & Lomb Incorporated

Other Identifiers

586

Identifier Type: -

Identifier Source: org_study_id