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CompletedNCT01001091Updated Jul 17, 2014

AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

A Phase 2 interventional study of AL-38583 ophthalmic solution and AL-38583 ophthalmic solution vehicle in Allergic Conjunctivitis, sponsored by Alcon Research. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-17.

Sponsored by Alcon Research · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
312
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the safety and efficacy of AL-38583 in the treatment of the signs of inflammation associated with allergic conjunctivitis.

02

Conditions studied

  • Allergic Conjunctivitis

Keywords

  • Conjunctivitis
  • conjunctival inflammation
  • ocular allergies
03

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 312 is above the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

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

Inclusion criteria

  • Presence of signs and symptoms of ocular inflammation in both eyes.
  • Have a positive CAC response at Visit 1.
  • Able to avoid the use of disallowed medications as well as contact lens wear for the specified period prior to Visit 1, and for the duration of the study.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

  • Have known history or presence of persistent dry eye syndrome.
  • Presence of any ophthalmic abnormality that may affect the study outcomes.
  • Have a history of moderate to severe allergic asthma reaction to mountain cedar or the perennial allergens used in the study.
  • Other protocol-defined exclusion criteria may apply.
05

Study design

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

Study arms

  • Experimental
    AL-38583 0.01%

    AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks

    Drug: AL-38583 ophthalmic solution

  • Experimental
    AL-38583 0.05%

    AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks

    Drug: AL-38583 ophthalmic solution

  • Experimental
    AL-38583 0.2%

    AL-38583 ophthalmic solution, 1 drop instilled in each eye 3 times per day for 2 weeks

    Drug: AL-38583 ophthalmic solution

  • Placebo comparator
    AL-38583 Vehicle

    AL-38583 ophthalmic solution vehicle, 1 drop instilled in each eye 3 times per day for 2 weeks

    Drug: AL-38583 ophthalmic solution vehicle

  • Active comparator
    MAXIDEX

    Dexamethasone ophthalmic suspension, 0.1%, 1 drop instilled in each eye 3 times per day for 2 weeks

    Drug: Dexamethasone ophthalmic suspension, 0.1%

Interventions

  • DrugAL-38583 ophthalmic solution
  • DrugAL-38583 ophthalmic solution vehicle

    Inactive ingredients used as a placebo comparator

  • DrugDexamethasone ophthalmic suspension, 0.1%

    Also known as: MAXIDEX

06

What researchers measure

Primary outcomes

  1. Mean area under the curve 0-7 hours post-CAC for conjunctival redness scores

    Time frame: Day 14

Secondary outcomes

  1. Mean daily diary ocular redness scores

    Time frame: 2 week period between Day 0 and Day 14

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01001091
Lead sponsor
Alcon Research
Collaborators
Ophthalmic Research Associates, Inc.
Responsible party
Sponsor
First posted
Oct 23, 2009
Start date
Dec 2009
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Jul 17, 2014

Study contacts

Michela Palmer
study director · Alcon Research

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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