0.1% Sodium Hyaluronate Eye Drops
Drug1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.
Other names: Hialid®,Santen Pharmaceutical(China) Co., Ltd
NCT Number: NCT07679685
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.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Phase 4
Beijing Anzhen Hospital, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.
Other names: Hialid®,Santen Pharmaceutical(China) Co., Ltd
1 drop per eye, 4 times daily (3-5 hour intervals between doses), applied bilaterally to the lower conjunctival sac, for 8 weeks.
Other names: Hengqin®, Chengdu Shengdi Pharmaceutical Co., Ltd.
Time frame: week 8
Change from Baseline in Fluorescein Tear Film Break-Up Time (FBUT) at Week 8
Time frame: Weeks 2, 4, and 8
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.
Time frame: Weeks 2, 4, and 8
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.
Time frame: Weeks 2, 4, and 8
Change from Baseline in Partial Blink Rate (PBR) at Weeks 2, 4, and 8
Time frame: Weeks 2, 4, and 8
Change from Baseline in Non-Invasive Tear Film Break-Up Time (NIBUT) at Weeks 2, 4, and 8
Time frame: Weeks 2, 4, and 8
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.
Contact information is provided by the study sponsor or research team.
Beijing Tongren Hospital
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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