Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Olopatadine hydrochloride ophthalmic solution, 0.2%

Drug
Who is being recruted

Conjunctival Diseases+4

+ Conjunctivitis

+ Eye Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Phase 4
Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorAlcon Research
Last updated: August 18, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorAlcon Research
Last updated: August 18, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

17 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Conjunctival DiseasesConjunctivitisEye DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesConjunctivitis, Allergic

Criteria

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Iowa

Iowa City, United StatesOpen University of Iowa in Google Maps
CompletedOne Study Center