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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 22, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is 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
Other: AL-4943A Ophthalmic Solution Vehicle
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change from Baseline (Day 0) in Best Corrected Visual Acuity (BCVA) at Week 6 (Day 42) [ Time Frame: Baseline (Day 0), Week 6 (Day 42) ] [ Designated as safety issue: Yes ]
  • Change from Baseline (Day 0) in Intraocular Pressure at Week 6 (Day 42) [ Time Frame: Baseline (Day 0), Week 6 (Day 42) ] [ Designated as safety issue: Yes ]
    As measured by Goldmann applanation tonometry, or other age appropriate methods for subjects less than 18 years of age

  • Change from Baseline (Day 0) in Slit Lamp Biomicroscopy at Week 1 (Day 7) [ Time Frame: Baseline (Day 0), Week 1 (Day 7) ] [ Designated as safety issue: Yes ]
    Slit lamp parameters as follows: eyelids/conjunctiva, cornea, iris/anterior chamber, lens

  • Change from Baseline (Day 0) in Slit Lamp Biomicroscopy at Week 3 (Day 21) [ Time Frame: Baseline (Day 0), Week 3 (Day 21) ] [ Designated as safety issue: Yes ]
    Slit lamp parameters as follows: eyelids/conjunctiva, cornea, iris/anterior chamber, lens

  • Change from Baseline (Day 0) in Slit Lamp Biomicroscopy at Week 6 (Day 42) [ Time Frame: Baseline (Day 0), Week 6 (Day 42) ] [ Designated as safety issue: Yes ]
    Slit lamp parameters as follows: eyelids/conjunctiva, cornea, iris/anterior chamber, lens

  • Change from Baseline (Day 0) in Dilated Fundoscopy at Week 6 (Day 42) [ Time Frame: Baseline (Day 0), Week 6 (Day 42) ] [ Designated as safety issue: Yes ]
    Fundoscopy parameters as follows: optic nerve, retina/vitreous, macula

  • Change from Baseline (Day 0) in Systolic Blood Pressure at Week 6 (Day 42) [ Time Frame: Baseline (Day 0), Week 6 (Day 42) ] [ Designated as safety issue: Yes ]
  • Change from Baseline (Day 0) in Diastolic Blood Pressure at Week 6 (Day 42) [ Time Frame: Baseline (Day 0), Week 6 (Day 42) ] [ Designated as safety issue: Yes ]
  • Change from Baseline (Day 0) in Heart Rate at Week 6 (Day 42) [ Time Frame: Baseline (Day 0), Week 6 (Day 42) ] [ Designated as safety issue: Yes ]
  • Change from Baseline (Day 0) in Best Corrected Visual Acuity (BCVA) at Week 3 (Day 21) [ Time Frame: Baseline (Day 0), Week 3 (Day 21) ] [ Designated as safety issue: Yes ]
  • Change from Baseline (Day 0) in Best Corrected Visual Acuity (BCVA) at Week 1 Day 7) [ Time Frame: Baseline (Day 0), Week 1 (Day 7) ] [ Designated as safety issue: Yes ]

Enrollment: 500
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
One drop AL-4943A ophthalmic solution once daily in both eyes for up to 6 weeks
 Drug: AL-4943A Ophthalmic Solution
One drop AL-4943A ophthalmic solution once daily in both eyes for up to 6 weeks
Placebo Comparator: AL-4943A Vehicle
One drop AL-4943A ophthalmic solution vehicle once daily in both eyes for up to 6 weeks
 Other: AL-4943A Ophthalmic Solution Vehicle
One drop AL-4943A ophthalmic solution vehicle once daily in both eyes for up to 6 weeks

  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 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.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Females: Pregnant, nursing, planning pregnancy, not using adequate birth control.
  • 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-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698814

Locations
United States, Texas
Contact Alcon for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Tiffany Wolcott 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
Last Updated: February 22, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Alcon Research:
ocular safety
allergic conjunctivitis
olopatadine

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 May 23, 2013