One Month Daily Wear Clinical Evaluation of New Prototype Contact Lenses in Habitual and Neophyte Contact Lens Wearers
2018年6月18日 更新者：Johnson & Johnson Vision Care, Inc.
One Month Daily Wear Clinical Evaluation of Three Prototype Soft Contact Lenses in a Population of Habitual and Neophyte Contact Lens Wearers
There will be four study lenses tested; one marketed lens, and three prototype study lenses.
Subjects will be randomized to one of the four study lenses which will be worn in a daily wear modality, with a two week replacement.
調査の概要
研究の種類
介入
入学 (実際)
80
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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Tamil Nadu
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Chennai、Tamil Nadu、インド、600 006
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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
18年～39年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
- The subject must be between 18 and 39 years of age.
- The subject must be able to read and understand English.
- The subject read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
- The subject must not have been a participant in a contact lens or contact lens solution study/investigation in the previous seven days.
- The subject must be willing to wearthe study lenses for at least 6 hours per day, 7 days per week (e.g. does not regularly swim).
- The subject must appear able and willing and able to the adhere to the instructions set forth in this clinical protocol.
- The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -4.00D in each eye.
- The subject's refractive astigamatism must be less than or equal to -1.00D in both eyes.
- The subjet must have best corrected visual acuity of 20/30 (6/9 or +0.20 logMAR) or better in each eye.
- The subject must require a visual correction in both eyes (no monofit or monovision allowed).
The subject must have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- No amblyopia
- No evidence of lid abnormality or infection (including blepharitis/meibomitis)
- No conjunctival abnormality or infection.
- No clinically significant slit lamp findings (i.e. stromal edema, vascularization, corneal scaring, infiltrates or abnormal opacities).
- No other active ocular diseases.
Exclusion Criteria:
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic diseases, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- Clinically significant (Grade 3 or 4) corneal edeam, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid permeable contact lens wear.
- Pregnancy or lactation (subjects who become pregnant during the study will be discontinued).
- No extended wear in the last 3 months.
- Diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or immunosuppressive disease (e.g. HIV).
- Has had refractive surgery.
- Employee of VRF with direct involvement in the study or a family member of the clinic.
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：etafilcon A
Marketed control soft contact lens
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worn in a daily wear modality; lenses will be replaced after 2 weeks
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実験的：Prototype E1
Investigational soft contact lens
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worn in a daily wear modality; lenses will be replaced after 2 weeks
他の名前：
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実験的：Prototype E2
Investigational soft contact lens
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worn in a daily wear modality; lenses will be replaced after 2 weeks
他の名前：
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実験的：Prototype E3
Investigational soft contact lens
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worn in a daily wear modality; lenses will be replaced after 2 weeks
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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Corneal Staining (Area)
時間枠：Baseline and 4-Week Follow-up
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Corneal Staining Area was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 11-point scale (i.e.
Grade 0= 0% of region covered, Grade 1 =10% of region covered, Grade 2 = 20% of region covered, Grade 3 = 30% of region covered, Grade 4= 40% of region covered, Grade 5 = 50% of region covered, Grade 6 = 60% of region covered,Grade 7 = 70% of region covered, Grade 8 = 80% of region covered, Grade 9 = 90% of region covered and Grade 10 = 100% of region covered).
Central, interior, nasal, temporal and superior locations were evaluated.
The average grade for each lens and time point was reported.
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Baseline and 4-Week Follow-up
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Corneal Staining (Depth)
時間枠：Baseline and 4-Week Follow-up
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Corneal Staining Depth was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 4-point scale (i.e.
Grade 0= None, Grade 1 =Superficial epithelial, Grade 2 = Full epithelial, Grade 3 =stromal glow).
Central, interior, nasal, temporal and superior locations were evaluated.
The average grade for each lens and time point was reported.
|
Baseline and 4-Week Follow-up
|
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Corneal Staining (Type)
時間枠：Baseline and 4-Week Follow-up
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Corneal Staining was collected at baseline and 4- week evaluations in both eyes using a slit lamp and was graded with a 5-point scale (i.e.
Grade 0= None, Grade 1 =Micropunctate, Grade 2 = Macropunctate, Grade 3 = Coalesced Macropunctate and Grade 4 = Patch (greater or equal to 1mm).
Central, interior, nasal, temporal and superior locations were evaluated.
The average grade for each lens and time point was reported.
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Baseline and 4-Week Follow-up
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Limbal Conjunctival Redness
時間枠：Baseline and 2-Week Follow-up
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Limbal Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations.
Limbal Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for limbal redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe).
The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance.
The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.
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Baseline and 2-Week Follow-up
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Bulbar Conjunctival Redness
時間枠：Baseline and 2-Week Follow-up
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Bulbar Conjunctival Redness was assessed for each subject and eye at baseline and 2-week follow-up evaluations.
Bulbar Redness was assessed in 4 regions Inferior, Nasal, Temporal and Superior and Graded using an Efron Grading scale for bulbar redness in 0.5 unit increments (Grade 0:None, Grade 1:Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe).
The average Grade across all four regions can range from 0 to 16 where lower values indicate better performance.
The average Grade for each individual region can range from 0 to 4. The average grade across all regions was reported for each lens and time point.
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Baseline and 2-Week Follow-up
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Visual Acuity (LogMAR)
時間枠：4-Week Follow-up
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Visual Acuity (LogMAR) was assessed bionocularly at the 4-week follow-up evaluations.
The average visual acuity (LogMAR) for each lens was reported.
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4-Week Follow-up
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Lens Fitting Characteristics
時間枠：Post Lens Fitting and 4-Week Follow-up
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Lens fit was assessed for each subject eye at post lens fitting and 4- week follow-up evaluations.
Lens fit is a binary response as acceptable or unacceptable lens fit.
The percentage of eyes with acceptable lens fit was reported.
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Post Lens Fitting and 4-Week Follow-up
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Percentage of Reported Ocular Symptoms (Burning/Stinging)
時間枠：Baseline and 4-Week Follow-up
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The Ocular symptom Burning/Stinging was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear.
The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
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Baseline and 4-Week Follow-up
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Corneal Edema
時間枠：Baseline and 4-Week Follow-up
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Corneal Edema was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe).
The Percentage of eyes with Grade 3 or higher was reported.
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Baseline and 4-Week Follow-up
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Conjunctival Injection
時間枠：Baseline and 4-Week Follow-up
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Conjunctival Injection was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe).
The Percentage of eyes with Grade 3 or higher was reported.
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Baseline and 4-Week Follow-up
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Corneal Neovascularization
時間枠：Baseline and 4-Week Follow-up
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Corneal Neovascularization was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe).
The Percentage of eyes with Grade 3 or higher was reported.
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Baseline and 4-Week Follow-up
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Corneal Staining
時間枠：Baseline and 4-Week Follow-up
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Corneal Staining was assessed using a bio-microscope at baseline and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe).
The Percentage of eyes with Grade 3 or higher was reported.
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Baseline and 4-Week Follow-up
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Tarsal Abnormalities
時間枠：1-, 2- and 4-Week Follow-up
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Tarsal abnormalities were assessed using a biomicroscope at baseline, post lens fitting, 1-, 2- and 4- week evaluations in both eyes and was graded with a 5-point scale (Grade 0, 1, 2, 3 and 4) with grade 0 represents the absence of abnormalities and 1 to 4 representing successively worse abnormalities (i.e.
Grade 0= None, Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe).
The percentage of eyes with Grade 3 or higher was reported.
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1-, 2- and 4-Week Follow-up
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Percentage of Reported Ocular Symptoms (Cloudy/Blurry/Hazy)
時間枠：Baseline and 4-Week Follow-up
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The Ocular symptom Cloudy/Blurry/Hazy was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear.
The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
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Baseline and 4-Week Follow-up
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Percentage of Reported Ocular Symptoms (Dryness)
時間枠：Baseline and 4-Week Follow-up
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The Ocular symptom Dryness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear.
The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
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Baseline and 4-Week Follow-up
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Percentage of Reported Ocular Symptoms (Grittiness/Foreign Body Sensation)
時間枠：Baseline and 4-Week Follow-up
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The Ocular symptom Grittiness/Foreign Body Sensation was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear.
The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
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Baseline and 4-Week Follow-up
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Percentage of Reported Ocular Symptoms (Irritation/Discomfort)
時間枠：Baseline and 4-Week Follow-up
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The Ocular symptom Irritation/Discomfort was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear.
The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
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Baseline and 4-Week Follow-up
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Percentage of Reported Ocular Symptoms (Itchiness/Scratchiness)
時間枠：Baseline and 4-Week Follow-up
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The Ocular symptom Itchiness/Scratchiness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear.
The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
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Baseline and 4-Week Follow-up
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Percentage of Reported Ocular Symptoms (Lens Awareness)
時間枠：Baseline and 4-Week Follow-up
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The Ocular symptom Lens awareness was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear.
The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
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Baseline and 4-Week Follow-up
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Percentage of Reported Ocular Symptoms (Redness)
時間枠：Baseline and 4-Week Follow-up
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The Ocular symptom Redness wasassessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear.
The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
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Baseline and 4-Week Follow-up
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Percentage of Reported Ocular Symptoms (Variable Vision)
時間枠：Baseline and 4-Week Follow-up
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The Ocular symptom Variable Vision was assessed by an individual item on a questionnaire and are subject reported, using the response scale of (N/A or Not recorded, Mild and rarely interferes with wear, Moderate and/or occasionally interferes with wear and Severe and/or frequently interferes with wear.
The percentage of Moderate or severe symptoms were reported for the initial visit as well as the 1 month follow-up.
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Baseline and 4-Week Follow-up
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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。
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2月6日
一次修了 (実際)
2014年6月25日
研究の完了 (実際)
2014年6月25日
試験登録日
最初に提出
2014年3月5日
QC基準を満たした最初の提出物
2014年3月6日
最初の投稿 (見積もり)
2014年3月7日
学習記録の更新
投稿された最後の更新 (実際)
2018年6月19日
QC基準を満たした最後の更新が送信されました
2018年6月18日
最終確認日
2017年7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
- CR-5146
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
はい
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。