Effect of Preservative-free Low-dose Hyaluronic Acid-containing Salt Solution on Dry Eye Disease

Dry Eye Clinical Trial

Official title:

Short-term Supplemental Effect of Preservative-free Low-dose Hyaluronic Acid-containing Salt Solution on Dry Eye Disease - A Randomized, Parallel-group, Double-blind, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03888183
• Other study ID #: 201801577A3C601
• Status: Recruiting
• Phase: Phase 4
• Start date: April 17, 2019
• Est. completion date: March 22, 2020

Study information

• Verified date: September 2019
• Source: Chang Gung Memorial Hospital
• Contact: Ing-Chou Lai, MD
• Phone: 886-9-75056482
• Email: lai1[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is a randomized, parallel-group, double-blind, controlled clinical trial to evaluate the effect of hyaluronic acid (HA) on dry eye disease.

Description:

This trial is a randomized, parallel-group, double-blind, controlled clinical trial to compare intervention treatment (Per-Young Eye Drops: preservative-free 0.15% HA) against control treatment (AIM Artificial Tears: salt solution without 0.15% HA). All participants will be received Per-Young Eye Drops (4 to 8 times per day) or AIM Artificial Tears (4 to 8 times per day) with 12 weeks. Two drugs are identical in appearance and order of administration will be double-blind randomized.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 334
• Est. completion date: March 22, 2020
• Est. primary completion date: January 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Male or female subjects aged greater than or equal to 20 years (>= 20 years).

• 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:

• Male or female subjects aged less than 20 years (<20 years).

• 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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear meniscus height	To compare the TMHc after blink of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA at 4 weeks.	4 weeks
Secondary	Tear meniscus height	To compare the TMHc of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA .	8 weeks and 12 weeks
Secondary	Ocular surface disease index (OSDI) score	To compare the OSDI score of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA. It was ranged from 0-100, in which higher score related to more severe symptom. It was subgroup into normal (0-12), mild (13-22), moderate(23-32), and severe (33-100).	8 weeks and 12 weeks
Secondary	Redness score	To compare the redness score of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA. It was obtained by Keratograph® 5M, Oculus. The redness score, including total redness score, temporal and nasal bulbar scores, temporal and nasal limbal redness scores, showing the severity of dry eye. The higher redness area imply more severity of dry eye.	8 weeks and 12 weeks
Secondary	Lipid layer thickness	To compare the lipid layer thickness of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA.	8 weeks and 12 weeks
Secondary	Tear film dynamics	To compare the tear film dynamics of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA.	8 weeks, 12 weeks
Secondary	Non-invasive tear break-up time (NITBUT)	To compare the NITBUT of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA.	8 weeks, 12 weeks
Secondary	Tear fern test	To compare the tear fern test of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA.	8 weeks, 12 weeks
Secondary	Ocular surface staining	To compare the ocular surface staining of treatment with preservative-free 0.15% HA to the treatment with salt solution without 0.15% HA. The ocular surface staining will be graded according to the Oxford Scheme. Fluorescein stain is applied on the ocular surface, and then corneal and conjunctival staining are evaluated under absorption filters. Staining will be labeled by punctate dots on a series of panels in order of increasing severity and score ranges from 0 to 5 for the treatment eye.	8 weeks, 12 weeks