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

September 17, 2019 updated by: Ing-Chou Lai, MD, Chang Gung Memorial Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

334

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan
        • Recruiting
        • Kaohsiung Chang Gung Memorial Hospital
        • Contact:
          • Ing-Chou Lai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: salt solution without 0.15% HA
Drug: salt solution without 0.15% HA
received AIM Artificial Tears (4 to 8 times per day) with 12 weeks
Other Names:
  • AIM Artificial Tears
Active Comparator: preservative-free 0.15% HA
Drug: preservative-free 0.15% HA
received Per-Young Eye Drops (4 to 8 times per day) with 12 weeks
Other Names:
  • Per-Young Eye Drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear meniscus height
Time Frame: 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tear meniscus height
Time Frame: 8 weeks and 12 weeks
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
Ocular surface disease index (OSDI) score
Time Frame: 8 weeks and 12 weeks
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
Redness score
Time Frame: 8 weeks and 12 weeks
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
Lipid layer thickness
Time Frame: 8 weeks and 12 weeks
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
Tear film dynamics
Time Frame: 8 weeks, 12 weeks
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
Non-invasive tear break-up time (NITBUT)
Time Frame: 8 weeks, 12 weeks
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
Tear fern test
Time Frame: 8 weeks, 12 weeks
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
Ocular surface staining
Time Frame: 8 weeks, 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Ing-Chou Lai, MD, Department of Ophthalmology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2019

Primary Completion (Anticipated)

January 22, 2020

Study Completion (Anticipated)

March 22, 2020

Study Registration Dates

First Submitted

March 20, 2019

First Submitted That Met QC Criteria

March 22, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201801577A3C601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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