Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients

Allergic Conjunctivitis Clinical Trial

Official title:

Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Pre and Post Treatment With Olopatadine HCL Ophthalmic Solution, 0.2%

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697969
• Other study ID #: M-12-047
• Status: Completed
• Phase: Phase 4
• First received: September 27, 2012
• Last updated: July 30, 2014
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to descriptively evaluate the corneal structures of allergic conjunctivitis patients.

Description:

Heidelberg Retina Tomograph (HRT) will be used to descriptively evaluate the corneal structures and assess the immune cell status of allergic conjunctivitis patients pre- and post-treatment with olopatadine 0.2% in relation to a normative database.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Read, sign, and date an Ethics Committee reviewed and approved informed consent form.

• Females of childbearing potential who:

• Are not breast-feeding;

• Do not intend to become pregnant for the duration of the study;

• Are using adequate birth control methods and agree to continue for the duration of the study.

• Able to read, understand and answer questions by investigator.

• Willing and able to attend all required study visits and follow directions as stipulated by the protocol and investigator.

• History of allergic conjunctivitis (within the past 12 months) and active signs and symptoms of ocular allergies for which treatment is necessary, in the opinion of the investigator.

• Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with or without glasses correction.

• Ocular health within normal limits as determined by the investigator.

• No contact lens wear 14 days prior to enrollment and willing to not wear contact lenses for the duration of the study.

• Willing to follow a 14-day washout period due to contraindicated medication use, if deemed necessary by investigator.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Contraindications or hypersensitivity to the use of the test article or its components.

• Inability or unwillingness to follow all study instructions and complete study visits as required.

• Only one sighted eye or visual acuity not correctable to 20/30 (Snellen) in both eyes at the Screening Visit.

• Ocular trauma within 6 months prior to Visit 1 in either eye.

• Any ocular surgical intervention within six months prior to Visit 1 or anticipation of ocular surgery during the study.

• Presumed or actual ocular infection within 30 days prior to Visit 1.

• Any severe or serious ocular condition or significant illness.

• Any abnormal slit-lamp findings at the time of the Screening Visit.

• Contact lens wear within 14 days prior to the study start and unwillingness to undergo a wash-out period of 14 days; unwilling to not wear contact lenses for the duration of the study.

• Use of over-the-counter (OTC) ocular medications within the past 14 days unless willing to follow wash out period.

• Use of topical or systemic ocular medications requiring longer than a two-week washout period.

• Participation in any other investigational study in the 30-day period before entry into this study (i.e., Visit 1) or concomitantly with this study.

• Women who are pregnant, nursing, or of childbearing potential not utilizing adequate birth control measures.

• Other protocol-defined exclusion criteria may apply.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• Olopatadine hydrochloride ophthalmic solution, 0.2%

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient-Assessed Ocular Itching	The patient rated the severity of ocular itching using a predetermined 0-4 scale, where 0=none and 4=severe itching with irresistible urge to rub. Each eye was rated separately. A 2-week washout period from prior allergy medication (if applicable) preceded the baseline assessment.	Baseline (Day 1), Day 14	No