Effect of Preservative-free Low-dose Hyaluronic Acid-containing Salt Solution on Dry Eye Disease
NCT ID: NCT03888183
Last Updated: 2019-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
334 participants
INTERVENTIONAL
2019-04-17
2020-03-22
Brief Summary
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Detailed Description
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Primary endpoint:
To compare the central tear meniscus height (TMHc) of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA at 4 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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salt solution without 0.15% HA
salt solution without 0.15% HA
received AIM Artificial Tears (4 to 8 times per day) with 12 weeks
preservative-free 0.15% HA
preservative-free 0.15% HA
received Per-Young Eye Drops (4 to 8 times per day) with 12 weeks
Interventions
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salt solution without 0.15% HA
received AIM Artificial Tears (4 to 8 times per day) with 12 weeks
preservative-free 0.15% HA
received Per-Young Eye Drops (4 to 8 times per day) with 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The symptom criterium of ocular surface disease index (OSDI) score \> 13.
* One of the two following examination criteria:
1. Central tear meniscus height (TMHc) \< 0.20 mm,
2. Noninvasive tear-break time (NITBUT) \< 6 s, for at least one eye.
* Informed consent form (ICF) signed by the participant or a legal guardian.
Exclusion Criteria
* The symptom criterium of ocular surface disease index (OSDI) score \< 13.
* Central tear meniscus height (TMHc) \> 0.20 mm and Noninvasive tear-break time (NITBUT) \> 6 s for each eye.
* Acute inflammatory eye diseases.
* Receive ocular or eyelid surgeries before 6 months (except cataract surgery).
* Allergy to HA
* Pregnancy
* Conditions judged by the investigator as unsuitable for this trial.
20 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Ing-Chou Lai, MD
Principal Investigator
Principal Investigators
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Ing-Chou Lai, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Ophthalmology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan
Locations
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Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Ing-Chou Lai, MD
Role: primary
References
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Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012 May;31(5):472-8. doi: 10.1097/ICO.0b013e318225415a.
Cho WH, Lai IC, Fang PC, Chien CC, Tseng SL, Lai YH, Huang YT, Kuo MT. Meibomian Gland Performance in Glaucomatous Patients With Long-term Instillation of IOP-lowering Medications. J Glaucoma. 2018 Feb;27(2):176-183. doi: 10.1097/IJG.0000000000000841.
Ho RW, Fang PC, Chao TL, Chien CC, Kuo MT. Increase lipid tear thickness after botulinum neurotoxin A injection in patients with blepharospasm and hemifacial spasm. Sci Rep. 2018 May 30;8(1):8367. doi: 10.1038/s41598-018-26750-5.
Wang CY, Ho RW, Fang PC, Yu HJ, Chien CC, Hsiao CC, Kuo MT. The function and morphology of Meibomian glands in patients with thyroid eye disease: a preliminary study. BMC Ophthalmol. 2018 Apr 12;18(1):90. doi: 10.1186/s12886-018-0763-9.
Other Identifiers
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201801577A3C601
Identifier Type: -
Identifier Source: org_study_id
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