AL-38583 Ophthalmic Solution for Allergic Conjunctivitis Associated Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety and Efficacy Study of AL-53817 and AL-78843 Ophthalmic Solutions for Allergic Conjunctivitis

NCT02079649

Allergic Conjunctivitis

COMPLETED PHASE2

A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye

NCT00893139

Dry Eye

COMPLETED PHASE2

DEXTENZA Therapy for Treatment of Allergic Conjunctivitis

NCT04708821

Bilateral Conjunctivitis (Disorder)

COMPLETED PHASE4

A Six-Week Safety Study of an Investigational Ophthalmic Solution

NCT01698814

Allergic Conjunctivitis

COMPLETED PHASE3

A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis

NCT04050865

Allergic Conjunctivitis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Allergic Conjunctivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AL-38583 0.01%

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

Group Type EXPERIMENTAL

AL-38583 ophthalmic solution

Intervention Type DRUG

AL-38583 0.05%

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

Group Type EXPERIMENTAL

AL-38583 ophthalmic solution

Intervention Type DRUG

AL-38583 0.2%

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

Group Type EXPERIMENTAL

AL-38583 ophthalmic solution

Intervention Type DRUG

AL-38583 Vehicle

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

Group Type PLACEBO_COMPARATOR

AL-38583 ophthalmic solution vehicle

Intervention Type DRUG

Inactive ingredients used as a placebo comparator

MAXIDEX

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

Group Type ACTIVE_COMPARATOR

Dexamethasone ophthalmic suspension, 0.1%

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AL-38583 ophthalmic solution

Intervention Type DRUG

AL-38583 ophthalmic solution vehicle

Inactive ingredients used as a placebo comparator

Intervention Type DRUG

Dexamethasone ophthalmic suspension, 0.1%

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MAXIDEX

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No