A Six-Week Safety Study of an Investigational Ophthalmic Solution

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01698814
First received: September 27, 2012
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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 Intervention Phase
Allergic Conjunctivitis
Drug: AL-4943A Ophthalmic Solution
Drug: AL-4943A Ophthalmic Solution Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AL-4943A Ophthalmic Solution Administered Once Daily

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Adverse Events [ Time Frame: An average of 6 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 518
Study Start Date: October 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01698814

Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Terri Pasquine Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01698814     History of Changes
Other Study ID Numbers: C-12-028
Study First Received: September 27, 2012
Results First Received: January 21, 2014
Last Updated: February 27, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
ocular safety
allergic conjunctivitis

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

ClinicalTrials.gov processed this record on July 23, 2014