Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients

NCT01697969 | Completed Phase 4 Results

• 1 other identifier: M-12-047
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Conjunctivitis

Keywords

allergic conjunctivitis; Pataday; Olopatadine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Pataday

EXPERIMENTAL

Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days

Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%

Interventions

Olopatadine hydrochloride ophthalmic solution, 0.2% DRUG

Also known as: PATADAY®

Pataday

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242-1091, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Olopatadine Hydrochloride

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

Limitations and Caveats

The lack of concurrent control made it difficult to discriminate changes caused by PATADAY® from that caused by other factors, such as observer or patient expectation. Open-labeled design increased the bias from the observer or patient expectation.

Results Point of Contact

• Title: Danyel Crout Carr, MS, CCRA
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Christine Sindt, OD, FAAO

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Pam Kaur, MS PhD

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2012
• First Posted: October 2, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 18, 2014
• Results First Posted: August 18, 2014

Record last verified: 2014-07

Locations

US (1)