Safety and Comfort of AL-4943A Ophthalmic Solution

NCT01326858 | Completed Phase 1

• 1 other identifier: C-10-127
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the ocular comfort and safety of olopatadine hydrochloride opthalmic solution. 0.7%.

Conditions

Allergic Conjunctivitis

Keywords

Ocular discomfort; AL-4943A Ophthalmic Solution

Outcome Measures

Primary Outcomes (1)

• Peak discomfort score over a 3-minute period after drop instillation

  Ocular discomfort as measured by Visual Analog Scale (VAS) with 0=none to 50=severe, was assessed by subjects every 30 seconds between 0 to 180 seconds after drop instillation (at 0, 30, 60, 90, 120, 150, and 180 seconds). Peak discomfort (maximum observed VAS discomfort score over the 3-minute period) for each subject in each period was analyzed.

  Up to Day 3

Secondary Outcomes (2)

• Ocular Symptoms

  Up to Day 3

• Product Acceptability

  Up to Day 3

Study Arms (3)

Olopatadine, 0.7%

EXPERIMENTAL

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

Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%; Drug: Olopatadine hydrochloride ophthalmic solution vehicle; Drug: Ketotifen fumarate ophthalmic solution, 0.025%

Vehicle

PLACEBO COMPARATOR

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

Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%; Drug: Olopatadine hydrochloride ophthalmic solution vehicle; Drug: Ketotifen fumarate ophthalmic solution, 0.025%

Zaditor

ACTIVE COMPARATOR

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

Drug: Olopatadine hydrochloride ophthalmic solution, 0.7%; Drug: Olopatadine hydrochloride ophthalmic solution vehicle; Drug: Ketotifen fumarate ophthalmic solution, 0.025%

Interventions

Olopatadine hydrochloride ophthalmic solution, 0.7% DRUG

Treatment A

Also known as: AL-4943A

Olopatadine, 0.7%; Vehicle; Zaditor

Olopatadine hydrochloride ophthalmic solution vehicle DRUG

Treatment B, inactive ingredients used as placebo

Olopatadine, 0.7%; Vehicle; Zaditor

Ketotifen fumarate ophthalmic solution, 0.025% DRUG

Treatment C

Also known as: Zaditor®

Olopatadine, 0.7%; Vehicle; Zaditor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Olopatadine Hydrochloride; ketotifen fumarate ophthalmic solution

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dibenzoxepins; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Abhijit Narvekar, MS, MBBS

  Alcon Research

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: March 31, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 3, 2015

Record last verified: 2015-02