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CompletedNCT00836485Updated Aug 4, 2023

Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

A Phase 2 interventional study of Ketotifen 4.0% Patch and Placebo in Allergic Conjunctivitis, sponsored by Senju USA, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-08-04.

Sponsored by Senju USA, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
122
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.

02

Conditions studied

  • Allergic Conjunctivitis
03

In context

Conjunctivitis, Allergic

210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.

This study's enrollment of 122 is above the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.

Browse Conjunctivitis, Allergic studies →

Lead sponsor

Senju USA, Inc. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years of age of either sex and any race
  • positive history of ocular allergies and a positive skin test reaction to cat hair, cat dander, dog dander, grasses, ragweed, trees, dust mites, and/or cockroaches within the past 24 months
  • able and willing to avoid all disallowed medication for the and during the study

Exclusion criteria

Exclusion Criteria:

  • active ocular infection or skin condition
  • ocular surgery within the past 3 months
  • pregnancy or nursing
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
122 participants (actual)

Study arms

  • Experimental
    1

    Ketotifen 4.0% Patch

    Drug: Ketotifen 4.0% Patch

  • Placebo comparator
    2

    Placebo Patch

    Drug: Placebo

  • Active comparator
    3

    Pataday(TM)

    Drug: Olopatadine 0.2%

  • Placebo comparator
    4

    Placebo eye drops

    Drug: Artificial tears

Interventions

  • DrugKetotifen 4.0% Patch

    This investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours.

  • DrugPlacebo

    The control is a placebo patch that contains only the inactive ingredients of ketotifen.

  • DrugOlopatadine 0.2%

    1 gtt/eye on two separate occasions

    Also known as: Pataday(TM)

  • DrugArtificial tears

    1 gtt/eye on two separate occasions

06

What researchers measure

Primary outcomes

  1. Ocular itching and bulbar conjunctival redness

    Time frame: Visit 3 and Visit 4

Secondary outcomes

  1. Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge

    Time frame: Visit 3 and Visit 4

  2. Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms

    Time frame: Visit 3 and Visit 4

07

Study locations

1 site
  • Ora
    Andover, Massachusetts 01810, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2009, a primary completion of Mar 2009 and a completion of Mar 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2009
First posted
Feb 4, 2009
Start
Feb 2009
Primary completionActual
Mar 2009
CompletionActual
Mar 2009
Results delay requested
Jun 5, 2017
Last update
Aug 4, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00836485
Lead sponsor
Senju USA, Inc.
Responsible party
Sponsor
First posted
Feb 4, 2009
Start date
Feb 2009
Primary completion
Mar 2009
Completion
Mar 2009
Last update
Aug 4, 2023

Study contacts

Gail Torkildsen, MD
principal investigator · ORA, Inc.
TBD TBD
principal investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Ketotifen

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Conjunctivitis, Allergic →

Other studies from this sponsor

Senju USA, Inc.

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