Trials Sponsors Conditions Drugs Pricing

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

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

Study Arms (2)

KetoNaph

EXPERIMENTAL

KetoNaph Ophthalmic Solution

Drug: KetoNaph

Vehicle

PLACEBO COMPARATOR

Vehicle of KetoNaph Ophthalmic Solution

Drug: Vehicle

Interventions

KetoNaphDrug

Ophthalmic Solution administered BID for 6 weeks

KetoNaph

VehicleDrug

Vehicle of KetoNaph ophthalmic solution administered bid for six weeks

Vehicle

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age2 Years+

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Bausch & Lomb Incorporated
Industrylead

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Results Point of Contact

Title: Study Director
Organization: Bausch Health

Study Officials

Tuyen Ong, MD
Bausch & Lomb Incorporated
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

534 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: SCREENING
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 9, 2010

Study Start

July 2010

Date type not reported

This date has not been verified as actual or estimated.

Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

KetoNaph

Vehicle

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

KetoNaph

Vehicle

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record