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WithdrawnNCT01238783Updated Dec 1, 2011

Safety and Efficacy of AL-15469A 0.5% / AL-6515 0.3% Ophthalmic Suspension for Treatment of Bacterial Conjunctivitis

A Phase 2 interventional study of AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension and AL-15469A 0.5% in Bacterial Conjunctivitis, sponsored by Alcon Research. Withdrawn. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2011-12-01.

Sponsored by Alcon Research (part of Alcon) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
5 Years and older
Sex
All
01

Study summary

To assess safety and efficacy of AL-15469A 0.5% /AL-6515 0.3% Ophthalmic Suspension for treatment of bacterial conjunctivitis

02

Conditions studied

  • Bacterial Conjunctivitis
03

In context

Conjunctivitis, Bacterial

40 studies on the registry are indexed under Conjunctivitis, Bacterial; 2 are open to participants now.

Browse Conjunctivitis, Bacterial studies →

Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.

Browse Alcon Research studies →All Alcon studies →

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

04

Who can participate

Ages eligible
5 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

  • Male and female patients of any race
  • 5 years of age and older at the time of the Day 1 visit
  • with a primary clinical diagnosis of bacterial conjunctivitis.

Exclusion criteria

Exclusion Criteria:

  • Onset of bacterial conjunctivitis (signs and symptoms) more than 4 days
  • Presence of punctal plug or punctal occlusion
  • Visual Acuity worse than 20/80
  • Upper respiratory infection
05

Study design

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

Study arms

  • Experimental
    AL-15469A 0.5% and AL-65150.3% Ophthalmic Suspension

    Drug: AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension

  • Experimental
    AL-15469A 0.5%

    Drug: AL-15469A 0.5%

  • Experimental
    AL-6515 0.3%

    Drug: AL-6515 0.3%

  • Placebo comparator
    Vehicle

    Drug: Vehicle

Interventions

  • DrugAL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension

    Drug page: Moxifloxacin

    Topical ocular dosed 3 times per day for 3 days

  • DrugAL-15469A 0.5%

    Topical ocular dosed 3 times per day for 3 days

  • DrugAL-6515 0.3%

    Topical ocular dosed 3 times per day for 3 days

  • DrugVehicle

    Topical ocular dosed 3 times per day for 3 days

06

What researchers measure

Primary outcomes

  1. Sustained Clinical Cure rate

    Time frame: Day 3

  2. End of therapy Clinical Cure rate

    Time frame: Day 4

Secondary outcomes

  1. Sustained bulbar conjunctival injection

    Time frame: Day 3

  2. Microbiological Success

    Time frame: Day 4

07

Study locations

No study locations are listed for this record.

08

Timeline

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

The record gives a start of Jan 2011 and a primary completion of Dec 2011. 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
Nov 9, 2010
First posted
Nov 11, 2010
Start
Jan 2011
Primary completionEst.
Dec 2011
Last update
Dec 1, 2011
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.
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 Dec 1, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01238783
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Nov 11, 2010
Start date
Jan 2011
Primary completion
Dec 2011 (estimated)
Last update
Dec 1, 2011

Oversight

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

Not currently enrolling

This study is withdrawn, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Moxifloxacin · Nepafenac

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