Contact Lens Adaptation in Neophytes (CLAN)
2022年9月19日 更新者：Andrew Pucker、Ohio State University
Eye care professionals prescribe contact lenses to new wearers on a daily basis, and it is common practice for practitioners to educate their patients to gradually increase their contact lens wear time over their first few days of use; however, there is no scientific basis in the literature for this practice.
This study will compare the ocular health and comfort of new contact lens wearers who are randomly assigned to begin contact lens wear with increasing wearing time versus those who immediately start full-time wear (eight hours or more/day).
The increasing wearing time group will wear daily wear contact lenses (Acuvue Oasys) for two, four, six, eight, and eight or more hours on the first, second, third, fourth, and fifth days, respectively.
The other group will be instructed to wear the same contact lenses for eight or more hours per day, starting with the first day of wear.
Both groups of subjects will have their eye health and comfort evaluated at baseline, one, and two weeks with a lighted-microscope and eye comfort surveys.
Subjects will also keep a daily log of eye comfort with a visual analog scale survey at home.
All subjects will learn how to wear and take care of contact lenses.
They will also receive a prescription for contact lenses at the conclusion if they wish to continue wearing the study contact lenses.
調査の概要
研究の種類
介入
入学 (実際)
25
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Ohio
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Columbus、Ohio、アメリカ、43210
- The Ohio State University
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
8年歳以上 (子、大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Has had a completed comprehensive eye exam within the past 6 months
- Able to wear spherical senofilcon A contact lenses
- Able to use Opti-Free PureMoist contact lens solution
Exclusion Criteria:
- Any prior contact lens use
- Topical eye drops within the last two hours of the study visit
- Known systemic health conditions known to alter tear film physiology
- History of severe ocular trauma
- Active ocular infection
- Active ocular inflammation
- Known hypersensitivity to diagnostic eye drops
- Pregnant or breast feeding
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Full-Time Senofilcon A Contact Lens Wear
This group will start wearing contact lenses 8 or more hours per day on the first day of wear
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他の名前：
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実験的：Graduated Senofilcon A Contact Lens Wear
This group will start wearing contact lenses on a graduated schedule (day 1 = 2 hours, day 2 = 4 hours, day 3 = 6 hours, day 4 = 8 hours, day 5 = 8 or more hours).
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他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Between-Group Difference in Eye Comfort as Measured by the Ocular Surface Disease Index (OSDI)
時間枠：2 weeks
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This is an eye comfort survey.
The Ocular Surface Disease Index (OSDI) is assessed on a scale of 0 to 100, with higher scores representing greater disability.
The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease.
The OSDI is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
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2 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Between-Group Difference in Visual Acuity as Measured With the Bailey-Lovie Chart
時間枠：2 weeks
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The investigator will measure the subject's visual acuity with a Bailey-Lovie high-contrast paper (logMAR) chart.
logMAR is a method used to observe visual acuity.
Smaller numbers are better scores.
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2 weeks
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Between-Group Difference in Tear Stability as Measured by Non-Invasive Break Up Time (NIBUT)
時間枠：2 Weeks
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Non-Invasive Break Up Time (NIBUT) is a measure of tear stability.
The range is 0 to 60 seconds with longer times being better tear stability.
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2 Weeks
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Between-Group Difference in Tear Volume as Measured by Tear Meniscus Height (TMH)
時間枠：2 Weeks
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Tear Meniscus Height (TMH) was used at a measure of tear volume.
The range is 0.0 to 2.0 mm with higher values being more tear volume.
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2 Weeks
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Between-Group Difference in Bulbar Conjunctival Redness as Measured With the Keratograph 5M
時間枠：2 Weeks
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Eye redness was measured via bulbar conjunctival redness as measured with the Keratograph 5M.
The range is 0 to 4 units with lower numbers being better.
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2 Weeks
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Between-Group Difference in Upper and Lower Eyelid Blepharitis
時間枠：2 Weeks
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A slit-lamp biomicroscope was used to document eyelid blepharitis with a 0-3 scale by each eyelid with higher scores being worse blepharitis.
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2 Weeks
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Between-Group Difference in Corneal Sodium Fluorescein Staining
時間枠：2 Weeks
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The Brien Holden Vision Institute grading scale was used to evaluate staining by observing the eye after applying sodium fluorescein.
Scores were given for the extent (0-20 units), depth (0-20 units), type (0-20 units) of staining.
Higher scores indicate worse staining.
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2 Weeks
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Between-Group Difference in Tear Volume as Measured by Schirmer's Test I
時間枠：2 Weeks
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Tear volume was assessed with Schirmer's Test I test over 5 mins.
This test has a 0-35 mm range with higher values being better tear volume.
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2 Weeks
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Between-Group Difference in End of Day Contact Lens Comfort as Measured With a Visual Analog Scale (VAS)
時間枠：2 Weeks
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End of day contact lens comfort was measured with a visual analog scale (1-100 scale).
Higher scores indicate better comfort.
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2 Weeks
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Between-Group Difference in Contact Lens Dry Eye-8 Questionnaire (CLDEQ-8) Scores
時間枠：2-Weeks
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Contact lens comfort was measured with a scale (1-37 scale).
Lower scores indicate better comfort.
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2-Weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Andrew D Pucker, OD, MS、Ohio State University
- 主任研究者：Jeffrey J Walline, OD, PhD、Ohio State University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Sullivan BD, Whitmer D, Nichols KK, Tomlinson A, Foulks GN, Geerling G, Pepose JS, Kosheleff V, Porreco A, Lemp MA. An objective approach to dry eye disease severity. Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6125-30. doi: 10.1167/iovs.10-5390. Epub 2010 Jul 14.
- Sullivan BD, Crews LA, Sonmez B, de la Paz MF, Comert E, Charoenrook V, de Araujo AL, Pepose JS, Berg MS, Kosheleff VP, Lemp MA. Clinical utility of objective tests for dry eye disease: variability over time and implications for clinical trials and disease management. Cornea. 2012 Sep;31(9):1000-8. doi: 10.1097/ICO.0b013e318242fd60.
- Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. doi: 10.1097/00003226-200310000-00008.
- Yang SN, Tai YC, Sheedy JE, Kinoshita B, Lampa M, Kern JR. Comparative effect of lens care solutions on blink rate, ocular discomfort and visual performance. Ophthalmic Physiol Opt. 2012 Sep;32(5):412-20. doi: 10.1111/j.1475-1313.2012.00922.x. Epub 2012 Jul 7.
- Dougherty BE, Nichols JJ, Nichols KK. Rasch analysis of the Ocular Surface Disease Index (OSDI). Invest Ophthalmol Vis Sci. 2011 Nov 7;52(12):8630-5. doi: 10.1167/iovs.11-8027.
- Chalmers RL, Begley CG. Dryness symptoms among an unselected clinical population with and without contact lens wear. Cont Lens Anterior Eye. 2006 Mar;29(1):25-30. doi: 10.1016/j.clae.2005.12.004. Epub 2006 Jan 31.
- Faber E, Golding TR, Lowe R, Brennan NA. Effect of hydrogel lens wear on tear film stability. Optom Vis Sci. 1991 May;68(5):380-4. doi: 10.1097/00006324-199105000-00010.
- Efron N, Morgan PB, Katsara SS. Validation of grading scales for contact lens complications. Ophthalmic Physiol Opt. 2001 Jan;21(1):17-29.
- Pucker AD, Steele K, Rueff E, Franklin QX, McClure K, Savla K, Walline JJ. Contact Lens Adaption in Neophytes. Optom Vis Sci. 2021 Mar 1;98(3):266-271. doi: 10.1097/OPX.0000000000001662.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2014年5月1日
一次修了 (実際)
2019年8月20日
研究の完了 (実際)
2019年9月3日
試験登録日
最初に提出
2014年5月21日
QC基準を満たした最初の提出物
2014年5月22日
最初の投稿 (見積もり)
2014年5月28日
学習記録の更新
投稿された最後の更新 (実際)
2022年9月29日
QC基準を満たした最後の更新が送信されました
2022年9月19日
最終確認日
2022年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2014H0074
- K08EY023264 (米国 NIH グラント/契約)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
セノフィルコンAの臨床試験
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ApexLens Co., Ltd.Chang Gung Memorial Hospital; Taipei Medical University WanFang Hospitalわからない