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Randomized Controlled Study on 3% Sodium Diquafosate and 0.1% Sodium Hyaluronate in the Treatment of Dry Eye Induced by Orthokeratology Lenses

Randomized Controlled Study on 3% Sodium Diquafosate and 0.1% Sodium Hyaluronate in the Treatment of Dry Eye Induced by Orthokeratology Lenses

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600117838
Enrollment
Unknown
Registered
2026-01-29
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry eye caused by prolonged wear of orthokeratology lenses

Interventions

experimental group:Gyogepipronate Sulfate Eye Drops
control group:Provide sodium hyaluronate eye drops

Sponsors

Hebei Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1.Ages 8 to 16 years old; 2.The subjects have worn orthokeratology lenses for at least one year, and they did not have dry eye when they first wore orthokeratology lenses. 3.Mild dry eye: Any one of the following signs:5 seconds < FBUT < 10 seconds ; 5 mm/5 min<= Schirmer I <= 10 mm/5 min without surface anesthesia ; TMH < 0.2 mm; 1 to 5 corneal fluorescein staining points Plus any one of the following symptoms Subjective symptoms such as dryness, foreign body sensation, burning sensation, fatigue, discomfort, and fluctuating vision in the eyes.

Exclusion criteria

Exclusion criteria: 1.Having other eye diseases besides dry eye syndrome; 2.Having other systemic diseases that may affect the ocular surface; 3.The subjects had received any dry eye treatment within 14 days prior to enrollment; 4.The subject has undergone other eye surgeries.; 5.Refusal to sign the informed consent form; 6.Unable to cooperate with the examination for an extended period of time;

Design outcomes

Primary

MeasureTime frame
Non-invasive tear film break-up time;

Secondary

MeasureTime frame
Ocular Surface Disease Index (OSDI-6) score;Meibomian gland score;Tear secretion;Uniformity of lipid layer distribution, color, and thickness;The number of corneal staining points;Non-invasive tear meniscus height;

Countries

China

Contacts

Public ContactLonghui Han

Hebei Eye Hospital

han-longhui@163.com+86 319 323 7966

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026