Phase 4
N=13
Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT01697969 ↗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
| Outcome | Result | p-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.
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.