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CompletedNCT01561521Updated Jul 18, 2013

An Evaluation of the Onset and Duration of Action of AKF-1 Ophthalmic Solution in Treating Acute Allergic Conjunctivitis

A Phase 3 interventional study of AKF-1 and AKF-1 in Allergic Conjunctivitis, sponsored by Akorn, Inc.. Completed at 1 site in United States. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2013-07-18.

Sponsored by Akorn, Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
10 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the onset and duration of action of two concentrations of AKF-1 Ophthalmic Solution compared to vehicle in the conjunctival allergen challenge (CAC) model of acute 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 90 is close to the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.

Browse Conjunctivitis, Allergic studies →

Lead sponsor

Akorn, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
10 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

  • positive bilateral conjunctival allergen challenge (CAC) reaction

Exclusion criteria

Exclusion Criteria:

  • known 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 medication during the period indicated prior to the enrollment or during the study
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.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

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

Study arms

  • Experimental
    AKF-1 0.025%

    Drug: AKF-1

  • Experimental
    AKF-1 0.035%

    Drug: AKF-1

  • Placebo comparator
    AKF-1 0%

    Drug: AKF-1

Interventions

  • DrugAKF-1

    1 drop AKF-1 0.025% in each eye at 2 separate times during a 14 day period

  • DrugAKF-1

    1 drop AKF-1 0.035% in each eye at 2 separate times during a 14 day period

  • DrugAKF-1

    1 drop 0% in each eye at 2 separate times during a 14 day period

06

What researchers measure

Primary outcomes

  1. Ocular Itching at defined time points up to 2 weeks

    Time frame: Baseline to day 14

  2. Ocular Redness at defined time points up to 2 weeks

    Time frame: Baseline to day 14

07

Study locations

1 site
  • Andover Eye Associates
    Andover, Massachusetts 01810, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01561521
Lead sponsor
Akorn, Inc.
Responsible party
Sponsor
First posted
Mar 23, 2012
Start date
Mar 2012
Primary completion
Apr 2012
Completion
Apr 2012
Last update
Jul 18, 2013

Oversight

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

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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