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CompletedNCT00769886Updated Apr 3, 2024Results posted

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

A Phase 3 interventional study of Ketotifen/naphazoline and Ketotifen in Allergic Conjunctivitis, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2024-04-03.

Sponsored by Bausch & Lomb Incorporated · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
6 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Conjunctivitis
03

Who can participate

Ages eligible
6 Years and older
Sexes eligible
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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
144 participants (actual)

Study arms

  • Experimental
    KetoNaph

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

    Drug: Ketotifen/naphazoline

  • Active comparator
    Naphazoline

    Naphazoline HCl 0.05% ophthalmic solution

    Drug: Naphazoline

  • Active comparator
    Ketotifen

    Ketotifen fumarate 0.025% ophthalmic solution

    Drug: Ketotifen

  • Placebo comparator
    Vehicle

    Vehicle of KetoNaph ophthalmic solution

    Drug: Vehicle

Interventions

  • DrugKetotifen/naphazoline

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

  • DrugKetotifen

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

  • DrugNaphazoline

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

  • DrugVehicle

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3, 5, and 7 minutes post challenge at 14 days

  2. 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.

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

Secondary outcomes

  1. Ciliary Redness

    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.

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

  2. Episcleral Redness

    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.

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

  3. Chemosis

    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.

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

  4. Eyelid Swelling

    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.

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

  5. Percentage of Eyes With Tearing

    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.

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

  6. Percentage of Eyes With Ocular Mucus Drainage

    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.

    Time frame: 7, 15, and 20 minutes post challenge at 14 days

06

Results

Posted Oct 27, 2020

Participant flow

Participant flow — Overall Study
MilestoneKetoNaphKetotifenNaphazolineVehicle
Started36363537
Completed31323435
Not completed5412

Outcome measures

PrimaryOcular 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.

Time frame:
3, 5, and 7 minutes post challenge at 14 days
Reported as:
Mean · score on a scale
Ocular Itching
score on a scaleKetoNaphKetotifenNaphazolineVehicle
3 minutes post-challenge0.50 ± 0.8350.49 ± 0.8601.87 ± 0.9321.93 ± 0.998
5 minutes post-challenge0.56 ± 0.7850.69 ± 0.9231.90 ± 0.9362.17 ± 0.885
7 minutes post-challenge0.56 ± 0.8560.72 ± 0.8851.75 ± 0.9711.97 ± 0.984
PrimaryConjunctival 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.

Time frame:
7, 15, and 20 minutes post challenge at 14 days
Reported as:
Mean · units on a scale
Conjunctival Hyperemia
units on a scaleKetoNaphKetotifenNaphazolineVehicle
7 minutes post-challenge1.13 ± 0.8721.49 ± 0.7611.62 ± 0.8602.24 ± 0.581
15 minutes post-challenge1.39 ± 0.8651.89 ± 0.7121.68 ± 0.9572.33 ± 0.551
20 minutes post-challenge1.26 ± 0.8181.77 ± 0.8051.53 ± 0.9592.24 ± 0.587
SecondaryCiliary Redness

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.

Time frame:
7, 15, and 20 minutes post challenge at 14 days
Reported as:
Mean · units on a scale
Ciliary Redness
units on a scaleKetoNaphKetotifenNaphazolineVehicle
7 minutes post-challenge1.05 ± 0.8731.39 ± 0.7741.66 ± 0.917—
15 minutes post-challenge1.28 ± 0.9071.79 ± 0.7911.71 ± 0.995—
20 minutes post-challenge1.15 ± 0.8541.77 ± 0.8101.58 ± 1.032—
SecondaryEpiscleral Redness

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.

Time frame:
7, 15, and 20 minutes post challenge at 14 days
Reported as:
Mean · score on a scale
Episcleral Redness
score on a scaleKetoNaphKetotifenNaphazolineVehicle
7 minutes post-challenge1.21 ± 0.8911.52 ± 0.7491.71 ± 0.951—
15 minutes post-challenge1.41 ± 0.8651.87 ± 0.7321.77 ± 0.988—
20 minutes post-challenge1.35 ± 0.8951.88 ± 0.7771.68 ± 1.026—
SecondaryChemosis

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.

Time frame:
7, 15, and 20 minutes post challenge at 14 days
Reported as:
Mean · score on a scale
Chemosis
score on a scaleKetoNaphKetotifenNaphazolineVehicle
7 minutes post-challenge0.22 ± 0.4100.22 ± 0.3130.51 ± 0.705—
15 minutes post-challenge0.29 ± 0.4880.42 ± 0.4200.66 ± 0.787—
20 minutes post-challenge0.34 ± 0.5490.41 ± 0.4500.66 ± 0.869—
SecondaryEyelid Swelling

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.

Time frame:
7, 15, and 20 minutes post challenge at 14 days
Reported as:
Mean · score on a scale
Eyelid Swelling
score on a scaleKetoNaphKetotifenNaphazolineVehicle
7 minutes post-challenge0.13 ± 0.3730.32 ± 0.6040.61 ± 0.783—
15 minutes post-challenge0.25 ± 0.5500.37 ± 0.6380.61 ± 0.746—
20 minutes post-challenge0.26 ± 0.5810.39 ± 0.6860.59 ± 0.729—
SecondaryPercentage of Eyes With Tearing

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.

Time frame:
7, 15, and 20 minutes post challenge at 14 days
Reported as:
Count of units · eyes
Percentage of Eyes With Tearing
eyesKetoNaphKetotifenNaphazolineVehicle
7 minutes post-challenge31123—
15 minutes post-challenge6716—
20 minutes post-challenge5713—
SecondaryPercentage of Eyes With Ocular Mucus Drainage

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.

Time frame:
7, 15, and 20 minutes post challenge at 14 days
Reported as:
Count of units · eyes
Percentage of Eyes With Ocular Mucus Drainage
eyesKetoNaphKetotifenNaphazolineVehicle
7 minutes post-challenge71213—
15 minutes post-challenge111918—
20 minutes post-challenge101618—

Adverse events

Collected over 14 days. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
KetoNaph—0/36 (0%)0/36 (0%)
Ketotifen—0/36 (0%)0/36 (0%)
Naphazoline—0/35 (0%)0/35 (0%)
Vehicle—0/37 (0%)0/37 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)KetoNaphKetotifenNaphazolineVehicleTotal
Mean33.63 (8 to 63)34.15 (10 to 71)35.56 (8 to 63)33.09 (9 to 71)34.10 (8 to 71)
Sex: Female, Male
Sex: Female, Male(Participants)KetoNaphKetotifenNaphazolineVehicleTotal
Female2018182177
Male1618171667
07

Study locations

1 site
  • Ophthalmic Research Consultants, Inc.
    North Andover, Massachusetts 01845, United States
08

Registry details

Key details

Study ID
NCT00769886
Lead sponsor
Bausch & Lomb Incorporated
Responsible party
Sponsor
First posted
Oct 9, 2008
Start date
Oct 2008
Primary completion
Dec 2008
Completion
Jun 2009
Results posted
Oct 27, 2020
Last update
Apr 3, 2024

Oversight

Data monitoring committee
No
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