NCT00769886

Brief Summary

The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
11.4 years until next milestone

Results Posted

Study results publicly available

October 27, 2020

Completed
Last Updated

April 3, 2024

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

October 8, 2008

Results QC Date

August 24, 2020

Last Update Submit

March 13, 2024

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (2)

  • Ocular Itching

    Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0 = None and 4.0 = Incapacitating itch with an irresistible urge to rub.

    3, 5, and 7 minutes post challenge at 14 days

  • Conjunctival Hyperemia

    Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0 = None and 4.0 = Extremely severe.

    7, 15, and 20 minutes post challenge at 14 days

Secondary Outcomes (6)

  • Ciliary Redness

    7, 15, and 20 minutes post challenge at 14 days

  • Episcleral Redness

    7, 15, and 20 minutes post challenge at 14 days

  • Chemosis

    7, 15, and 20 minutes post challenge at 14 days

  • Eyelid Swelling

    7, 15, and 20 minutes post challenge at 14 days

  • Percentage of Eyes With Tearing

    7, 15, and 20 minutes post challenge at 14 days

  • +1 more secondary outcomes

Study Arms (4)

KetoNaph

EXPERIMENTAL

KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution

Drug: Ketotifen/naphazoline

Naphazoline

ACTIVE COMPARATOR

Naphazoline HCl 0.05% ophthalmic solution

Drug: Naphazoline

Ketotifen

ACTIVE COMPARATOR

Ketotifen fumarate 0.025% ophthalmic solution

Drug: Ketotifen

Vehicle

PLACEBO COMPARATOR

Vehicle of KetoNaph ophthalmic solution

Drug: Vehicle

Interventions

Ketotifen/naphazolineDRUG

One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.

KetoNaph
KetotifenDRUG

One drop of Ketotifen in study eye at visit 3 and visit 4.

Ketotifen
NaphazolineDRUG

One drop of naphazoline in study eye at vist 3 and visit 4.

Naphazoline
VehicleDRUG

One drop of vehicle in study eye at visit 3 and visit 4.

Vehicle

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
  • Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
  • Positive bilateral conjunctival allergen challenge(CAC)reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
  • Positive bilateral CAC reaction in at least 2 out of 3 time points at visit 2.

You may not qualify if:

  • Known contraindications or sensitivities to the study medication or its components.
  • Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
  • Use of disallowed medications during the period indicated prior to study enrollment or during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmic Research Consultants, Inc.

North Andover, Massachusetts, 01845, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

KetotifenNaphazoline

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsImidazolesAzoles

Results Point of Contact

Title
Study Director
Organization
Bausch Health
susan.harris@bauschhealth.com
908-300-9920

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2008

First Posted

October 9, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2008

Study Completion

June 1, 2009

Last Updated

April 3, 2024

Results First Posted

October 27, 2020

Record last verified: 2020-10

Locations

US(1)