A Six-Week Safety Study of an Investigational Ophthalmic Solution

• ClinicalTrials.gov Identifier: NCT01698814
• Recruitment Status: Completed
• First Posted: October 3, 2012
• Results First Posted: February 28, 2014
• Last Update Posted: March 27, 2014
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 2 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Alcon Research

Investigators

• Study Director: Terri Pasquine; Alcon Research

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01698814
• Other Study ID Numbers: C-12-028
• First Posted: October 3, 2012
• 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; Conjunctivitis, Allergic; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Olopatadine Hydrochloride; Pharmaceutical Solutions; Ophthalmic Solutions; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; 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