Dispensing Clinical Trial of Comfilcon A Extended Range Multifocal Lenses
Comfilcon A 拡張範囲多焦点レンズの調剤臨床試験
The aim of this study is to validate the clinical of comfilcon A extended range high add center near (CN) multifocal lenses in existing contact lens wearers against the current comfilcon A high add multifocal lenses.
調査の概要
詳細な説明
This study is a 13-subject, randomized, prospective, single site, daily wear, single-masked (to the subject), bilateral, 4-day cross-over, dispensing study comparing the comfilcon A extended range multifocal test lens against the comfilcon A multifocal control lens.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Indiana
-
Bloomington、Indiana、アメリカ、47405
- CORL, Indiana University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
A person is eligible for inclusion in the study if he/she:
- Has had a self-reported oculo-visual examination in the last two years
- Is 50 years of age or greater and has full legal capacity to volunteer
- Is able to read and understand the informed consent
- Is willing and able to follow instructions and maintain the appointment schedule
- Has a spherical distance contact lens prescription between -1.00 and -5.00D (Diopters) (inclusive)
- Near Add Power requirement of +2.25D or greater
- Has spectacle cylinder 0.75 D in both eyes
- Has normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
- Has monocular best-corrected distance visual acuity of 20/30 or better in each eye
- Has clear corneas and no active ocular disease
- Has not worn gas permeable contact lenses for 1 month prior to the study
Exclusion Criteria:
A person will be excluded from the study if he/she:
- Has never worn contact lenses before
- Has any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has any ocular pathology or abnormality that would affect the wearing of contact lenses
- Is aphakic (i.e. missing their natural lens inside their eye)
- Has uncorrected anisometropia (i.e. difference in the prescription between the eyes) of ≥2.00 D
- Has undergone corneal refractive surgery
- Is participating in any other type of eye related clinical or research study.
研究計画
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：クロスオーバー割り当て
- 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 |
|---|---|
|
実験的：comfilcon A Extended Range test lens
Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. |
contact lens contact lens |
|
アクティブコンパレータ：comfilcon A control lens
Subjects will be randomized to wear either the test or control pair of lens, then cross over to the alternate pair. |
contact lens contact lens |
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 |
|---|---|---|
|
Visual Acuity
時間枠：4 days
|
Visual acuity was measured at distance, intermediate and near conditions for test and control lens was assessed by LogMAR. |
4 days
|
|
Visual Performance
時間枠：4 days
|
Subjective assessment of visual performance for test and control lens is assessed on a scale 0-100, 0=extremely poor vision all of the time and cannot function, 100= excellent vision all of the time). |
4 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Subjective Ratings for Comfort
時間枠：Baseline
|
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). |
Baseline
|
|
Subjective Ratings for Comfort
時間枠：4 days
|
Subjective ratings for comfort was assessed for test and control lens on a Scale 0-100, 0=cannot be worn, causes pain, 100=cannot be felt ever). |
4 days
|
|
Subjective Ratings for Dryness
時間枠：Baseline
|
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). |
Baseline
|
|
Subjective Ratings for Dryness
時間枠：4 days
|
Subjective ratings for dryness was assessed for test and control lens on a scale 0-100, 0=cannot be worn, extremely dry, 100=no dryness experienced at any time). |
4 days
|
|
Lens Handling
時間枠：4 Days
|
Subjective ratings for handling (ease of insertion and removal) was assessed for test and control lens on a scale 0-100, 0=very difficult to handle, 100=easy to handle). |
4 Days
|
|
Average Daily Wearing Time
時間枠：4 days
|
Average daily wearing time for test and control lens is assessed in hours. |
4 days
|
|
Lens Fit
時間枠：4 days
|
Lens fit acceptance (general fit characteristics) is assessed for test and control lens on a 0-4 grading system in 0.25 steps where 0 represented very poor fit. |
4 days
|
|
Bulbar Hyperemia
時間枠：4 days
|
Bulbar hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. |
4 days
|
|
Limbal Hyperemia
時間枠：4 days
|
Limbal hyperemia was assessed on a scale of 0-4 and was used in 0.50 steps, with 0 indicating no hyperemia and 4 indicating severe hyperemia. |
4 days
|
|
Subjective Satisfaction
時間枠：4 days
|
Subjective satisfaction for test and control lens was assessed on a scale 0-100, 0=extremely dissatisfied, 100=very satisfied) |
4 days
|
|
Subjective Preference for Near Vision
時間枠：4 days
|
Subjective preference for near vision for test and control contact lenses. comfort, vision, handling, satisfaction. |
4 days
|
|
Subjective Preference for Distance Vision
時間枠：4 days
|
Subjective preference for distance vision for test and control contact lenses. |
4 days
|
|
Subjective Preference for Intermediate Vision
時間枠：4 days
|
Subjective preference for intermediate vision for test and control contact lenses. |
4 days
|
|
Subjective Preference for Overall Vision
時間枠：4 days
|
Subjective preference for overall vision for test and control contact lenses. |
4 days
|
|
Subjective Preference for Comfort
時間枠：4 days
|
Subjective preference for comfort for test and control contact lenses. |
4 days
|
|
Subjective Overall Lens Preference
時間枠：4 days
|
Subjective overall lens preference for test and control contact lenses. |
4 days
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Pete S Kollbaum, O.D.、Indiana University
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (推定)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。