Safety and Comfort of AL-4943A Ophthalmic Solution

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

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-06-30

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 ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.

Related Clinical Trials

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

An Open-Label, Long-Term Study With AL-4943A Ophthalmic Solution, 0.2% in Patients With Allergic Conjunctivitis

NCT01037179

Allergic Conjunctivitis

COMPLETED PHASE3

A Six-Week Safety Study of an Investigational Ophthalmic Solution

NCT01698814

Allergic Conjunctivitis

COMPLETED PHASE3

A Study of Patient Perception and Quality of Life Associated With the Use of Olopatadine 0.2% in Subjects With Allergic Conjunctivitis

NCT01272089

Allergic Conjunctivitis

COMPLETED PHASE4

Clinical Evaluation of 0.1% Olopatadine Hydrochloride Ophthalmic Solution in Pediatric Patients

NCT01109485

Allergic Conjunctivitis

COMPLETED PHASE4

Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis

NCT01258309

Rhinitis, Allergic, Seasonal Conjunctivitis, Allergic

COMPLETED PHASE3

Detailed Description

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

In this 3-treatment, 3-period, 6-sequence crossover study, each subject will receive all 3 products in randomized order, 1 product at a time, with a washout period of 24 hours between treatment periods. Following instillation of study medication, subjects will complete a 3-minute discomfort profile.

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

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

Olopatadine, 0.7%

Olopatadine hydrochloride ophthalmic solution, 0.7%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic vehicle and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized

Group Type EXPERIMENTAL

Olopatadine hydrochloride ophthalmic solution, 0.7%

Intervention Type DRUG

Treatment A

Olopatadine hydrochloride ophthalmic solution vehicle

Intervention Type DRUG

Treatment B, inactive ingredients used as placebo

Ketotifen fumarate ophthalmic solution, 0.025%

Intervention Type DRUG

Treatment C

Vehicle

Olopatadine hydrochloride ophthalmic solution vehicle, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and ketotifen fumarate ophthalmic solution, 0.025%, Periods 2 and 3, as randomized

Group Type PLACEBO_COMPARATOR

Olopatadine hydrochloride ophthalmic solution, 0.7%

Intervention Type DRUG

Treatment A

Olopatadine hydrochloride ophthalmic solution vehicle

Intervention Type DRUG

Treatment B, inactive ingredients used as placebo

Ketotifen fumarate ophthalmic solution, 0.025%

Intervention Type DRUG

Treatment C

Zaditor

Ketotifen fumarate ophthalmic solution, 0.025%, 1 drop instilled in each eye, 1 dose, in Period 1, followed by olopatadine hydrochloride ophthalmic solution, 0.7% and olopatadine hydrochloride ophthalmic solution vehicle, Periods 2 and 3, as randomized

Group Type ACTIVE_COMPARATOR

Olopatadine hydrochloride ophthalmic solution, 0.7%

Intervention Type DRUG

Treatment A

Olopatadine hydrochloride ophthalmic solution vehicle

Intervention Type DRUG

Treatment B, inactive ingredients used as placebo

Ketotifen fumarate ophthalmic solution, 0.025%

Intervention Type DRUG

Treatment C

Interventions

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

Olopatadine hydrochloride ophthalmic solution, 0.7%

Treatment A

Intervention Type DRUG

Olopatadine hydrochloride ophthalmic solution vehicle

Treatment B, inactive ingredients used as placebo

Intervention Type DRUG

Ketotifen fumarate ophthalmic solution, 0.025%

Treatment C

Intervention Type DRUG

Other Intervention Names

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

AL-4943A Zaditor®

Eligibility Criteria

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

Inclusion Criteria

* Able to be dosed in both eyes, to follow instructions, and willing and able to attend required study visits.
* Negative urine pregnancy test if female of childbearing potential and use adequate birth control throughout the study period.

Exclusion Criteria

* History or clinical evidence of ocular herpes simplex or ocular herpes zoster infectious disease.
* History of any clinically significant external ocular disease within 30 days of the start of the study.
* Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular surface/lid margin, active or chronic follicular conjunctivitis, preauricular adenopathy, or any other ocular or periocular abnormality that may affect the study outcomes.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes