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Phase 4 N=13

Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients

Allergic Conjunctivitis

Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Patient-Assessed Ocular Itching — 2.2; 2.2; 0.5; 0.5 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Olopatadine hydrochloride ophthalmic solution, 0.2% (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Alcon Research
Primary completion
Jul 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Patient-Assessed Ocular Itching
2.2; 2.2; 0.5; 0.5

Summary

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

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01697969). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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