Perfluorohexyloctane Eye Drops vs. Sodium Hyaluronate for Video Display Terminal-Associated Dry Eye
A Prospective, Multicenter, Randomized Controlled Trial on the Efficacy and Safety of Perfluorohexyloctane Eye Drops Versus 0.1% Sodium Hyaluronate Eye Drops in the Treatment of Video Display Terminal-associated Dry Eye
This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of perfluorohexyloctane (PFHO) eye drops (Hengqin®, Chengdu Shengdi Pharmaceutical Co., Ltd.) compared with 0.1% sodium hyaluronate eye drops in patients with video display terminal (VDT)-associated dry eye.
Participants aged 18-70 years with mild to moderate dry eye (confirmed by Chinese Dry Eye Expert Consensus 2020 criteria) who use video display terminal for more than 6 hours/day and at least 5 days/week for more than 1 year will be enrolled. A total of 159 subjects will be randomized in a 2:1 ratio to the experimental group (PFHO eye drops, n=106) or control group (0.1% sodium hyaluronate eye drops, n=53), both administered 1 drop/eye, 4 times daily (3-5 hour intervals), bilaterally, for 8 weeks.
The primary endpoint is the change from baseline in fluorescein tear film break-up time (FBUT) at Week 8. Secondary endpoints include FBUT changes at Weeks 2 and 4, standard patient evaluation of eye dryness（SPEED） questionnaire score changes, total corneal fluorescein staining (tCFS), partial blink rate (PBR), non-invasive tear film break-up time (NIBUT), lipid layer thickness (LLT), meibomian gland secretion quality score, and This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of perfluorohexyloctane (PFHO) eye drops (Hengqin®, Chengdu Shengdi Pharmaceutical Co., Ltd.) compared with 0.1% sodium hyaluronate eye drops (Hialid®) in patients with video display terminal (VDT)-associated dry eye.
Participants aged 18-70 years with mild to moderate dry eye (confirmed by Chinese Dry Eye Expert Consensus 2020 criteria) who use electronic screens for more than 6 hours/day and at least 5 days/week for more than 1 year will be enrolled. A total of 159 subjects will be randomized in a 2:1 ratio to the experimental group (PFHO eye drops, n=106) or control group (0.1% sodium hyaluronate eye drops, n=53), both administered 1 drop/eye, 4 times daily (3-5 hour intervals), bilaterally, for 8 weeks.
The primary endpoint is the change from baseline in fluorescein tear film break-up time (FBUT) at Week 8. Secondary endpoints include FBUT changes at Weeks 2 and 4, SPEED questionnaire score changes, total corneal fluorescein staining (tCFS), partial blink rate (PBR), non-invasive tear film break-up time (NIBUT), lipid layer thickness (LLT), meibomian gland secretion quality score, and meibography score at Weeks 2, 4, and 8.
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- フェーズ 4
連絡先と場所
研究連絡先
- 名前：Jin Yuan
- 電話番号：010-58366699
- メール：yuanjincornea@126.com
研究場所
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Beijing、中国
- Chinese PLA General Hospital
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コンタクト：
- Liqiang Wang
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Beijing、中国
- Peking Union Medical College Hospital
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コンタクト：
- Di Chen
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Beijing、中国
- Beijing Aier-Intech Eye Hospital
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Guangzhou、中国
- Guangdong Provincial People's Hospital
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コンタクト：
- Honghua Yu
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Guangzhou、中国
- Sun Yat-sen Memorial Hospital
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コンタクト：
- Yuqing Lan
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Shanghai、中国
- Eye & ENT Hospital of Fudan University
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コンタクト：
- Lan Gong
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Xi'an、中国
- Xi'an Fourth Hospital
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コンタクト：
- Ying Li
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Zhongshan、中国
- Zhongshan City People's Hospital
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コンタクト：
- Naiyang Li
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Beijing Municipality
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Beijing、Beijing Municipality、中国
- Beijing Anzhen Hospital
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コンタクト：
- Xinxiao Gao
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 18-70 years (inclusive), male or female;
- Subject reports dry eye symptoms for at least 6 months;
Diagnosis of mild to moderate dry eye according to the Chinese Dry Eye Expert Consensus (2020) criteria:
- Mild dry eye: fluorescein tear film break-up time (FBUT) ≥2 seconds, no significant ocular surface damage signs, corneal fluorescein staining score <5;
- Moderate dry eye: FBUT ≥2 seconds AND corneal fluorescein staining dots <30 or not exceeding 2 quadrants;
- Normal tear secretion: Schirmer I test ≥10 mm/5 min;
- Daily electronic screen usage >6 hours;
- Electronic screen use for at least 5 days/week, for more than 1 year;
- Understands and provides written informed consent.
Exclusion Criteria:
- Allergy or hypersensitivity to any component of the study drugs;
- Requires the use of artificial tears (other than study drug), secretagogues, ocular surface repair agents, anti-inflammatory/antibiotic eye drops, or other dry eye-related drugs (e.g., muscarinic receptor blockers for visual fatigue) during the study period;
Presence of any of the following ocular or systemic conditions:
- Active ocular infection, ocular inflammation, or active ocular allergy;
- Conjunctivochalasis, nasolacrimal duct obstruction;
- Glaucoma or elevated intraocular pressure;
- Retinal disease or ocular tumor;
- Requirement to wear contact lenses during the study;
- Obstructive sleep apnea syndrome or sleep disorders;
- Planned or ongoing physical therapy (intense pulsed light, meibomian gland massage, warm compress, thermopulsation) within 2 weeks before enrollment through the end of study;
- Ocular surgery within 3 months prior to enrollment, incomplete recovery from previous ocular surgery, or planned ophthalmic surgery during the study period;
- Current smoker;
- Pregnant or breastfeeding women, or women planning to become pregnant during the study period;
- Uncontrolled systemic disease, or use of systemic medications (e.g., beta-blockers, benzodiazepines, corticosteroids, antihistamines, or other medications that may interfere with tear production);
- History of anxiety or depression;
- Any other condition that, in the judgment of the investigator, would make the subject unsuitable for participation.
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：並列代入
- マスキング：なし（オープンラベル）
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：0.1% Sodium Hyaluronate Eye Drops
1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.
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1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.
他の名前：
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実験的：Perfluorohexyloctane Eye Drops (PFHO)
1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.
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1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 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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Fluorescein Tear Film Break-Up Time（FBUT）
時間枠：week 8
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Change from Baseline in Fluorescein Tear Film Break-Up Time (FBUT) at Week 8
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week 8
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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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standard patient evaluation of eye dryness（SPEED） Questionnaire
時間枠：Weeks 2, 4, and 8
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1.Change from Baseline in SPEED Questionnaire Score at Weeks 2, 4, and 8 2.Scores range from 0 to 28, with higher scores indicating more severe symptoms.
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Weeks 2, 4, and 8
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Total Corneal Fluorescein Staining Score (tCFS)
時間枠：Weeks 2, 4, and 8
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1.Change from Baseline in Total Corneal Fluorescein Staining Score (tCFS) at Weeks 2, 4, and 8；2.The cornea was divided into five regions: superior, central, inferior, nasal, and temporal.
Each region was scored from 0 to 3, yielding a total score ranging from 0 to 15, with higher scores indicating more severe signs.
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Weeks 2, 4, and 8
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Partial Blink Rate (PBR)
時間枠：Weeks 2, 4, and 8
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Change from Baseline in Partial Blink Rate (PBR) at Weeks 2, 4, and 8
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Weeks 2, 4, and 8
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Non-Invasive Tear Film Break-Up Time (NIBUT)
時間枠：Weeks 2, 4, and 8
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Change from Baseline in Non-Invasive Tear Film Break-Up Time (NIBUT) at Weeks 2, 4, and 8
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Weeks 2, 4, and 8
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Meibomian Gland Secretion Quality Score
時間枠：Weeks 2, 4, and 8
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1.Change from Baseline in Meibomian Gland Secretion Quality Score at Weeks 2, 4, and 8；2.The central lower eyelid margin was gently pressed with a cotton swab to evaluate five meibomian glands.
The secretion quality of each gland was graded on a scale of 0 to 3. The total score ranged from 0 to 15, with higher scores indicating poorer meibum quality.
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Weeks 2, 4, and 8
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Jin Yuan、Beijing Tongren Hospital
出版物と役立つリンク
一般刊行物
- Ccami-Bernal F, Soriano-Moreno DR, Romero-Robles MA, Barriga-Chambi F, Tuco KG, Castro-Diaz SD, Nunez-Lupaca JN, Pacheco-Mendoza J, Galvez-Olortegui T, Benites-Zapata VA. Prevalence of computer vision syndrome: A systematic review and meta-analysis. J Optom. 2024 Jan-Mar;17(1):100482. doi: 10.1016/j.optom.2023.100482. Epub 2023 Oct 30.
- Uchino M, Yokoi N, Uchino Y, Dogru M, Kawashima M, Komuro A, Sonomura Y, Kato H, Kinoshita S, Schaumberg DA, Tsubota K. Prevalence of dry eye disease and its risk factors in visual display terminal users: the Osaka study. Am J Ophthalmol. 2013 Oct;156(4):759-66. doi: 10.1016/j.ajo.2013.05.040. Epub 2013 Jul 24.
- Rossi GCM, Scudeller L, Bettio F, Pasinetti GM, Bianchi PE. Prevalence of dry eye in video display terminal users: a cross-sectional Caucasian study in Italy. Int Ophthalmol. 2019 Jun;39(6):1315-1322. doi: 10.1007/s10792-018-0947-6. Epub 2018 Jun 7.
- Wu H, Wang Y, Dong N, Yang F, Lin Z, Shang X, Li C. Meibomian gland dysfunction determines the severity of the dry eye conditions in visual display terminal workers. PLoS One. 2014 Aug 21;9(8):e105575. doi: 10.1371/journal.pone.0105575. eCollection 2014.
- Sheppard JD, Kurata F, Epitropoulos AT, Krosser S, Vittitow JL; MOJAVE Study Group. NOV03 for Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction: The Randomized Phase 3 MOJAVE Study. Am J Ophthalmol. 2023 Aug;252:265-274. doi: 10.1016/j.ajo.2023.03.008. Epub 2023 Mar 21.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- IIT-VDT-PFHO-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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
米国FDA規制機器製品の研究
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