AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

NCT01001091 | Completed Phase 2

• 1 other identifier: C-09-034
• Study Type: interventional
• Target: 312
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Allergic Conjunctivitis

Keywords

Conjunctivitis; conjunctival inflammation; ocular allergies

Outcome Measures

Primary Outcomes (1)

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

  Day 14

Secondary Outcomes (1)

• Mean daily diary ocular redness scores

  2 week period between Day 0 and Day 14

Study Arms (5)

AL-38583 0.01%

EXPERIMENTAL

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

Drug: AL-38583 ophthalmic solution

AL-38583 0.05%

EXPERIMENTAL

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

Drug: AL-38583 ophthalmic solution

AL-38583 0.2%

EXPERIMENTAL

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

Drug: AL-38583 ophthalmic solution

AL-38583 Vehicle

PLACEBO COMPARATOR

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

Drug: AL-38583 ophthalmic solution vehicle

MAXIDEX

ACTIVE COMPARATOR

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

AL-38583 ophthalmic solution DRUG

AL-38583 0.01%; AL-38583 0.05%; AL-38583 0.2%

AL-38583 ophthalmic solution vehicle DRUG

Inactive ingredients used as a placebo comparator

AL-38583 Vehicle

Dexamethasone ophthalmic suspension, 0.1% DRUG

Also known as: MAXIDEX

MAXIDEX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead
• Ophthalmic Research Associates, Inc.: collaborator

MeSH Terms

Conditions

Conjunctivitis, Allergic; Conjunctivitis

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Michela Palmer

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 23, 2009
• Study Start: December 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: July 17, 2014

Record last verified: 2014-07