Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT00769886
Collaborator
(none)
144
Enrollment
1
Location
4
Arms
8
Duration (Months)
18
Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Double-Masked, Randomized, Vehicle and Active Controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis
Study Start Date :
Oct 1, 2008
Actual Primary Completion Date :
Dec 1, 2008
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

ArmIntervention/Treatment
Experimental: KetoNaph

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

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

Active Comparator: Naphazoline

Naphazoline HCl 0.05% ophthalmic solution

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

Active Comparator: Ketotifen

Ketotifen fumarate 0.025% ophthalmic solution

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

Placebo Comparator: Vehicle

Vehicle of KetoNaph ophthalmic solution

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

Outcome Measures

Primary Outcome Measures

  1. Ocular Itching [3, 5, and 7 minutes post challenge at 14 days]

    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.

  2. Conjunctival Hyperemia [7, 15, and 20 minutes post challenge at 14 days]

    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.

Secondary Outcome Measures

  1. Ciliary Redness [7, 15, and 20 minutes post challenge at 14 days]

    Ciliary hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using a 0-4 scale, allowing 0.5- unit increments, with 0.0 = None and 4.0 = Extremely severe.

  2. Episcleral Redness [7, 15, and 20 minutes post challenge at 14 days]

    Episcleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using a 0-4 scale, allowing 0.5- unit increments, with 0.0 = None and 4.0 = Extremely severe.

  3. Chemosis [7, 15, and 20 minutes post challenge at 14 days]

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

  4. Eyelid Swelling [7, 15, and 20 minutes post challenge at 14 days]

    Lid swelling was evaluated by the subject at 7, 15, and 20 minutes post challenge on a 0- 3 numerical analog scale, with 0.5-unit increments disallowed, where: 0.0 = None and 3.0 = Severe.

  5. Percentage of Eyes With Tearing [7, 15, and 20 minutes post challenge at 14 days]

    Tearing was evaluated by the subject at 7, 15, and 20 minutes post challenge (absent or present). Tearing was recorded as either absent or present.

  6. Percentage of Eyes With Ocular Mucus Drainage [7, 15, and 20 minutes post challenge at 14 days]

    Ocular mucous discharge was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Mucous discharged was recorded as either absent or present.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • 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.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Ophthalmic Research Consultants, Inc.North AndoverMassachusettsUnited States01845

Sponsors and Collaborators

  • Bausch & Lomb Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00769886
Other Study ID Numbers:
  • 571
First Posted:
Oct 9, 2008
Last Update Posted:
Oct 27, 2020
Last Verified:
Oct 1, 2020

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleKetoNaphKetotifenNaphazolineVehicle
Arm/Group DescriptionKetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
Period Title: Overall Study
STARTED36363537
COMPLETED31323435
NOT COMPLETED5412

Baseline Characteristics

Arm/Group TitleKetoNaphKetotifenNaphazolineVehicleTotal
Arm/Group DescriptionKetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.Total of all reporting groups
Overall Participants36363537144
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]
33.63
34.15
35.56
33.09
34.10
Sex: Female, Male (Count of Participants)
Female
20
55.6%
18
50%
18
51.4%
21
56.8%
77
53.5%
Male
16
44.4%
18
50%
17
48.6%
16
43.2%
67
46.5%

Outcome Measures

1. Primary Outcome
TitleOcular Itching
DescriptionOcular 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.
Time Frame3, 5, and 7 minutes post challenge at 14 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleKetoNaphKetotifenNaphazolineVehicle
Arm/Group DescriptionKetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
Measure Participants36363537
Measure eyes72717074
3 minutes post-challenge
0.50
(0.835)
0.49
(0.860)
1.87
(0.932)
1.93
(0.998)
5 minutes post-challenge
0.56
(0.785)
0.69
(0.923)
1.90
(0.936)
2.17
(0.885)
7 minutes post-challenge
0.56
(0.856)
0.72
(0.885)
1.75
(0.971)
1.97
(0.984)
2. Primary Outcome
TitleConjunctival Hyperemia
DescriptionConjunctival 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.
Time Frame7, 15, and 20 minutes post challenge at 14 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleKetoNaphKetotifenNaphazolineVehicle
Arm/Group DescriptionKetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
Measure Participants36363537
Measure eyes72717074
7 minutes post-challenge
1.13
(0.872)
1.49
(0.761)
1.62
(0.860)
2.24
(0.581)
15 minutes post-challenge
1.39
(0.865)
1.89
(0.712)
1.68
(0.957)
2.33
(0.551)
20 minutes post-challenge
1.26
(0.818)
1.77
(0.805)
1.53
(0.959)
2.24
(0.587)
3. Secondary Outcome
TitleCiliary Redness
DescriptionCiliary hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using a 0-4 scale, allowing 0.5- unit increments, with 0.0 = None and 4.0 = Extremely severe.
Time Frame7, 15, and 20 minutes post challenge at 14 days

Outcome Measure Data

Analysis Population Description
This outcome measure was not assessed for the Vehicle group.
Arm/Group TitleKetoNaphKetotifenNaphazolineVehicle
Arm/Group DescriptionKetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
Measure Participants3636350
Measure eyes7271700
7 minutes post-challenge
1.05
(0.873)
1.39
(0.774)
1.66
(0.917)
15 minutes post-challenge
1.28
(0.907)
1.79
(0.791)
1.71
(0.995)
20 minutes post-challenge
1.15
(0.854)
1.77
(0.810)
1.58
(1.032)
4. Secondary Outcome
TitleEpiscleral Redness
DescriptionEpiscleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using a 0-4 scale, allowing 0.5- unit increments, with 0.0 = None and 4.0 = Extremely severe.
Time Frame7, 15, and 20 minutes post challenge at 14 days

Outcome Measure Data

Analysis Population Description
This outcome measure was not assessed for the Vehicle group.
Arm/Group TitleKetoNaphKetotifenNaphazolineVehicle
Arm/Group DescriptionKetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
Measure Participants3636350
Measure eyes7271700
7 minutes post-challenge
1.21
(0.891)
1.52
(0.749)
1.71
(0.951)
15 minutes post-challenge
1.41
(0.865)
1.87
(0.732)
1.77
(0.988)
20 minutes post-challenge
1.35
(0.895)
1.88
(0.777)
1.68
(1.026)
5. Secondary Outcome
TitleChemosis
DescriptionChemosis was evaluated by the Investigator at 7, 15, and 20 minutes post challenge on a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0 = None and 4.0 = Extremely severe.
Time Frame7, 15, and 20 minutes post challenge at 14 days

Outcome Measure Data

Analysis Population Description
This outcome measure was not assessed for the Vehicle group.
Arm/Group TitleKetoNaphKetotifenNaphazolineVehicle
Arm/Group DescriptionKetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
Measure Participants3636350
Measure eyes7271700
7 minutes post-challenge
0.22
(0.410)
0.22
(0.313)
0.51
(0.705)
15 minutes post-challenge
0.29
(0.488)
0.42
(0.420)
0.66
(0.787)
20 minutes post-challenge
0.34
(0.549)
0.41
(0.450)
0.66
(0.869)
6. Secondary Outcome
TitleEyelid Swelling
DescriptionLid swelling was evaluated by the subject at 7, 15, and 20 minutes post challenge on a 0- 3 numerical analog scale, with 0.5-unit increments disallowed, where: 0.0 = None and 3.0 = Severe.
Time Frame7, 15, and 20 minutes post challenge at 14 days

Outcome Measure Data

Analysis Population Description
This outcome measure was not assessed for the Vehicle group.
Arm/Group TitleKetoNaphKetotifenNaphazolineVehicle
Arm/Group DescriptionKetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
Measure Participants3636350
Measure eyes7271700
7 minutes post-challenge
0.13
(0.373)
0.32
(0.604)
0.61
(0.783)
15 minutes post-challenge
0.25
(0.550)
0.37
(0.638)
0.61
(0.746)
20 minutes post-challenge
0.26
(0.581)
0.39
(0.686)
0.59
(0.729)
7. Secondary Outcome
TitlePercentage of Eyes With Tearing
DescriptionTearing was evaluated by the subject at 7, 15, and 20 minutes post challenge (absent or present). Tearing was recorded as either absent or present.
Time Frame7, 15, and 20 minutes post challenge at 14 days

Outcome Measure Data

Analysis Population Description
This outcome measure was not assessed for the Vehicle group.
Arm/Group TitleKetoNaphKetotifenNaphazolineVehicle
Arm/Group DescriptionKetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
Measure Participants3636350
Measure eyes7271700
7 minutes post-challenge
3
11
23
15 minutes post-challenge
6
7
16
20 minutes post-challenge
5
7
13
8. Secondary Outcome
TitlePercentage of Eyes With Ocular Mucus Drainage
DescriptionOcular mucous discharge was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Mucous discharged was recorded as either absent or present.
Time Frame7, 15, and 20 minutes post challenge at 14 days

Outcome Measure Data

Analysis Population Description
This outcome measure was not assessed for the Vehicle group.
Arm/Group TitleKetoNaphKetotifenNaphazolineVehicle
Arm/Group DescriptionKetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
Measure Participants3636350
Measure eyes7271700
7 minutes post-challenge
7
12
13
15 minutes post-challenge
11
19
18
20 minutes post-challenge
10
16
18

Adverse Events

Time Frame14 days
Adverse Event Reporting Description
Arm/Group TitleKetoNaphKetotifenNaphazolineVehicle
Arm/Group DescriptionKetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution Ketotifen/naphazoline: One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.Ketotifen fumarate 0.025% ophthalmic solution Ketotifen: One drop of Ketotifen in study eye at visit 3 and visit 4.Naphazoline HCl 0.05% ophthalmic solution Naphazoline: One drop of naphazoline in study eye at vist 3 and visit 4.Vehicle of KetoNaph ophthalmic solution Vehicle: One drop of vehicle in study eye at visit 3 and visit 4.
All Cause Mortality
KetoNaphKetotifenNaphazolineVehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total/ (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
KetoNaphKetotifenNaphazolineVehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/36 (0%) 0/36 (0%) 0/35 (0%) 0/37 (0%)
Other (Not Including Serious) Adverse Events
KetoNaphKetotifenNaphazolineVehicle
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/36 (0%) 0/36 (0%) 0/35 (0%) 0/37 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Contact sponsor directly for details.

Results Point of Contact

Name/TitleStudy Director
OrganizationBausch Health
Phone908-300-9920
Emailsusan.harris@bauschhealth.com
Responsible Party:
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00769886
Other Study ID Numbers:
  • 571
First Posted:
Oct 9, 2008
Last Update Posted:
Oct 27, 2020
Last Verified:
Oct 1, 2020