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Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers

Primary Purpose

Allergic Conjunctivitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

KetoNaph

Vehicle

About this trial

This is an interventional screening trial for Allergic Conjunctivitis

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

KetoNaph

Vehicle

Arm Description

KetoNaph Ophthalmic Solution

Vehicle of KetoNaph Ophthalmic Solution

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01159015

First Posted

July 6, 2010

Last Updated

October 1, 2020

Sponsor

Bausch & Lomb Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01159015

Brief Title

Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers

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 Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

September 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bausch & Lomb Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Conjunctivitis

7. Study Design

Primary Purpose

Screening

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

534 (Actual)

8. Arms, Groups, and Interventions

Arm Title

KetoNaph

Arm Type

Experimental

Arm Description

KetoNaph Ophthalmic Solution

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

Vehicle of KetoNaph Ophthalmic Solution

Intervention Type

Drug

Intervention Name(s)

KetoNaph

Intervention Description

Ophthalmic Solution administered BID for 6 weeks

Intervention Type

Drug

Intervention Name(s)

Vehicle

Intervention Description

Vehicle of KetoNaph ophthalmic solution administered bid for six weeks

Primary Outcome Measure Information:

Title

Percentage of Participants With at Least One Adverse Event.

Description

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.

Time Frame

42 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tuyen Ong, MD

Organizational Affiliation

Bausch & Lomb Incorporated

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers

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