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Dry EyePhase 4NCT03888183

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

A Phase 4 study testing salt solution without 0.15% HA and preservative-free 0.15% HA in people with Dry Eye, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Dry Eye
What is being tested?
salt solution without 0.15% HA and preservative-free 0.15% HA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
334 participants
Where
1 siteTaiwan
Study dates
17 Apr 2019to 22 Mar 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Ing-Chou Lai, MD contact

886-9-75056482

lai1@cgmh.org.tw

Ming-Tse Kuo, MD, PhD contact

886-9-75056495

mingtse@cgmh.org.tw

Taiwan1 site, 1 recruiting

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City

    Ing-Chou Lai, MD

    Recruiting

Other trials in Taiwan

About this study

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

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

Read the 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.

Conditions
Dry Eye
Being tested
salt solution without 0.15% HA, preservative-free 0.15% HA
Keywords
hyaluronic acid, salt solution, dry eye disease, ocular surface disease
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • salt solution without 0.15% HADrug

    Also called AIM Artificial Tears

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

  • preservative-free 0.15% HADrug

    Also called Per-Young Eye Drops

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

Study groups in NCT03888183
Study groupRoleWhat they receive
salt solution without 0.15% HAPlacebo comparatorNot described
Receives: Drug: salt solution without 0.15% HA
preservative-free 0.15% HAActive comparatorNot described
Receives: Drug: preservative-free 0.15% HA

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 weeks

Secondary outcomes (8)

  1. 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 .

    Measured: 8 weeks and 12 weeks

  2. 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).

    Measured: 8 weeks and 12 weeks

  3. 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.

    Measured: 8 weeks and 12 weeks

  4. 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.

    Measured: 8 weeks and 12 weeks

  5. 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.

    Measured: 8 weeks, 12 weeks

  6. 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.

    Measured: 8 weeks, 12 weeks

  7. 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.

    Measured: 8 weeks, 12 weeks

  8. 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.

    Measured: 8 weeks, 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2019
  2. Study start17 Apr 2019
  3. Primary completion22 Jan 2020 (estimated)
  4. Study completion22 Mar 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
334 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03888183
Sponsor's protocol ID
201801577A3C601
Status last verified
Sep 2019
First submitted
20 Mar 2019
Last updated
19 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28736335

  • 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.

    PubMed 22378109

  • 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.

    PubMed 29240600

  • 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.

    PubMed 29849166

  • 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.

    PubMed 29649988

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing salt solution without 0.15% HA and preservative-free 0.15% HA in people with Dry Eye, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ing-Chou Lai, MD (886-9-75056482, lai1@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tear meniscus height (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03888183, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.

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