NCT03888183

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
334

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
23 days until next milestone

Study Start

First participant enrolled

April 17, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2020

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

9 months

First QC Date

March 20, 2019

Last Update Submit

September 17, 2019

Conditions

Dry Eye

Keywords

hyaluronic acidsalt solutiondry eye diseaseocular surface disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Tear meniscus height

    8 weeks and 12 weeks

  • Ocular surface disease index (OSDI) score

    8 weeks and 12 weeks

  • Redness score

    8 weeks and 12 weeks

  • Lipid layer thickness

    8 weeks and 12 weeks

  • Tear film dynamics

    8 weeks, 12 weeks

  • +3 more secondary outcomes

Study Arms (2)

salt solution without 0.15% HA

PLACEBO COMPARATOR
Drug: salt solution without 0.15% HA

preservative-free 0.15% HA

ACTIVE COMPARATOR
Drug: preservative-free 0.15% HA

Interventions

salt solution without 0.15% HADRUG

received AIM Artificial Tears (4 to 8 times per day) with 12 weeks

Also known as: AIM Artificial Tears
salt solution without 0.15% HA
preservative-free 0.15% HADRUG

received Per-Young Eye Drops (4 to 8 times per day) with 12 weeks

Also known as: Per-Young Eye Drops
preservative-free 0.15% HA

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • Central tear meniscus height (TMHc) \< 0.20 mm,
  • Noninvasive tear-break time (NITBUT) \< 6 s, for at least one eye.
  • Informed consent form (ICF) signed by the participant or a legal guardian.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 28736335BACKGROUND

  • 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.

    PMID: 22378109BACKGROUND

  • 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.

    PMID: 29240600BACKGROUND

  • 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.

    PMID: 29849166BACKGROUND

  • 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.

    PMID: 29649988BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Ing-Chou Lai, MD

    Department of Ophthalmology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ing-Chou Lai, MD

CONTACT

886-9-75056482lai1@cgmh.org.tw

Ming-Tse Kuo, MD, PhD

CONTACT

886-9-75056495mingtse@cgmh.org.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 20, 2019

First Posted

March 25, 2019

Study Start

April 17, 2019

Primary Completion

January 22, 2020

Study Completion

March 22, 2020

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)