Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients
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ClinicalTrials.gov Identifier: NCT01697969 |
Recruitment Status
:
Completed
First Posted
: October 2, 2012
Results First Posted
: August 18, 2014
Last Update Posted
: August 18, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Allergic Conjunctivitis | Drug: Olopatadine hydrochloride ophthalmic solution, 0.2% | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 17 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Official Title: | Confocal Analysis of Corneal Structures of Symptomatic Allergic Conjunctivitis Patients Pre and Post Treatment With Olopatadine HCL Ophthalmic Solution, 0.2% |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | July 2013 |
Actual Study Completion Date : | July 2013 |
Arm | Intervention/treatment |
---|---|
Experimental: Pataday
Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
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Drug: Olopatadine hydrochloride ophthalmic solution, 0.2%
Other Name: PATADAY®
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- Patient-Assessed Ocular Itching [ Time Frame: Baseline (Day 1), Day 14 ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01697969
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242-1091 |
Principal Investigator: | Christine Sindt, OD, FAAO | University of Iowa | |
Study Director: | Pam Kaur, MS PhD | Alcon Research |
Responsible Party: | Alcon Research |
ClinicalTrials.gov Identifier: | NCT01697969 History of Changes |
Other Study ID Numbers: |
M-12-047 |
First Posted: | October 2, 2012 Key Record Dates |
Results First Posted: | August 18, 2014 |
Last Update Posted: | August 18, 2014 |
Last Verified: | July 2014 |
Keywords provided by Alcon Research:
allergic conjunctivitis Pataday Olopatadine |
Additional relevant MeSH terms:
Conjunctivitis Conjunctivitis, Allergic Conjunctival Diseases Eye Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Pharmaceutical Solutions Ophthalmic Solutions Olopatadine Hydrochloride Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |