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

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ClinicalTrials.gov Identifier: NCT03888183
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
Ing-Chou Lai, MD, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Dry Eye Drug: salt solution without 0.15% HA Drug: preservative-free 0.15% HA Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 20, 2019
Estimated Primary Completion Date : January 20, 2020
Estimated Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Per-Young Eye Drops




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 .

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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. 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.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888183


Contacts
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Contact: Ing-Chou Lai, MD 886-9-75056482 lai1@cgmh.org.tw
Contact: Ming-Tse Kuo, MD, PhD 886-9-75056495 mingtse@cgmh.org.tw

Locations
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Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan
Contact: Ing-Chou Lai, MD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Ing-Chou Lai, MD Department of Ophthalmology, Chang Gung Memorial Hospital, Kaohsiung, Taiwan

Publications:
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Responsible Party: Ing-Chou Lai, MD, Principal Investigator, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03888183     History of Changes
Other Study ID Numbers: 201801577A3C601
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ing-Chou Lai, MD, Chang Gung Memorial Hospital:
hyaluronic acid
salt solution
dry eye disease
ocular surface disease

Additional relevant MeSH terms:
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Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Lubricant Eye Drops
Keratoconjunctivitis Sicca
Keratoconjunctivitis
Conjunctivitis
Keratitis
Pharmaceutical Solutions
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents