A Six-Week Safety Study of an Investigational Ophthalmic Solution

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01698814
Recruitment Status : Completed
First Posted : October 3, 2012
Results First Posted : February 28, 2014
Last Update Posted : March 27, 2014
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study was to evaluate the ocular safety of an investigational ophthalmic solution in subjects 2 years of age and older with asymptomatic eyes when administered once daily in both eyes for up to 6 weeks.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: AL-4943A Ophthalmic Solution Drug: AL-4943A Ophthalmic Solution Vehicle Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 518 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AL-4943A Ophthalmic Solution Administered Once Daily
Study Start Date : October 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Arm Intervention/treatment
Experimental: AL-4943A
AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
Drug: AL-4943A Ophthalmic Solution
Placebo Comparator: AL-4943A Vehicle
AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
Drug: AL-4943A Ophthalmic Solution Vehicle
Inactive ingredients used as placebo

Primary Outcome Measures :
  1. Adverse Events [ Time Frame: An average of 6 weeks ]
    An adverse event was defined as any untoward medical occurrence in a subject administered a study treatment regardless of causal relationship with the treatment. AEs were obtained as solicited comments from the study subjects and as observations by the study Investigator.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Able and willing to comply with study protocol and follow protocol instructions.
  • Adequate birth control methods for the duration of the study.
  • Best-corrected visual acuity (BCVA) of 55 or greater in each eye.
  • Willing to avoid contact lens wear during each of the study visits; contact lens wear also should be stable and consistent for 1 month prior to Visit 1 and expected to remain the same for the study duration.
  • Willing and able to sign an Informed Consent form.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Women of childbearing potential that are pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
  • Evidence of contact lens care solution related ocular surface damage or giant papillary conjunctivitis (GPC).
  • Any ocular infection (bacterial, viral or fungal) or history of ocular Herpes (simplex or zoster) or adenoviral infection in either eye or have had any ocular infection within 30 days prior to Visit 1.
  • Using systemic medication(s) on a chronic dosing regimen for less than 30 days or changed dosage of this medication within 30 days prior to Visit 1.
  • Current or past history of glaucoma or ocular hypertension.
  • History of retinal detachment, diabetic retinopathy, or progressive retinal disease.
  • Presence of ocular conditions that may affect the study outcomes.
  • Corneal conditions affecting the corneal structure.
  • History or evidence of any ocular surgical procedure within 1 year prior to Visit 1.
  • Current or recent medical conditions that, in the opinion of the Investigator, would preclude safe participation in the study.
  • Prior, current, or anticipated use of ophthalmic agents other than investigational product during study participation.
  • Participation in any investigational study within 30 days prior to Visit 1 or concomitantly with this study.
  • Known contraindications or hypersensitivities to any of the study medications or their components.
  • Other protocol-specified exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01698814

Sponsors and Collaborators
Alcon Research
Study Director: Terri Pasquine Alcon Research

Responsible Party: Alcon Research Identifier: NCT01698814     History of Changes
Other Study ID Numbers: C-12-028
First Posted: October 3, 2012    Key Record Dates
Results First Posted: February 28, 2014
Last Update Posted: March 27, 2014
Last Verified: February 2014

Keywords provided by Alcon Research:
ocular safety
allergic conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Olopatadine Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action