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Dry EyeNCT06158984

Managing Dry Eye in Patients Using Glaucoma Drops

A study testing IPL in people with Dry Eye, run by He Eye Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A single center randomized controlled trial on managing dry eye signs and symptoms in patients using anti-glaucoma eye drops. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Dry Eye
What is being tested?
IPL
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
3 Oct 2023to 2 Dec 2023
Phase
Interventional
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 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • Able and willing to comply with the treatment/follow-up schedule
  • Bilateral signs and symptoms of dry eye disease

Who cannot join

  • Participants with systemic immune-mediated illnesses, such as secondary Sjögren's syndrome or graft-versus-host disease
  • Patients using topical medication(s) for the treatment of ocular disorders such as allergic conjunctivitis were excluded from the study.
  • Previous ocular surgery or trauma
  • 1-month history of blepharal and periorbital skin disease or allergies
  • Severe dry eyes with corneal epithelial defect
  • Limbic keratitis
Show all 14Show fewer
  • Pterygium
  • Corneal neovascularization
  • Breastfeeding
  • Rheumatic immune systemic diseases
  • Herpes zoster infection
  • Pregnant women
  • Allergic to fluorescein
  • Contact lens wearers

Trial locations and contacts

1 site in 1 country.

China1 site

  • He Eye Hospital

    Shenyang, Liaoning, 110001

Other trials in China

About this study

A single center randomized controlled trial on managing dry eye signs and symptoms in patients using anti-glaucoma eye drops.

Read the detailed description

To compare the safety and efficacy of IPL therapy on drug-induced dry eye caused by long-term use of anti glaucoma drugs;

Conditions
Dry Eye
Being tested
IPL
Keywords
Glaucoma, IPL, Diquafosol, Drug-induced Dry Eye
Medical subject headings
Dry Eye Syndromes, Glaucoma

What participants receive

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

  • IPLDevice

    Also called Intense pulsed light

    Intense pulse light (IPL) therapy is used for the treatment of drug-related dry eye in glaucoma patients.

Study groups in NCT06158984
Study groupRoleWhat they receive
IPL groupExperimentalIPL group will use 2 sessions of IPL therapy, 15 days apart for the management of drug-induced dry eye in glaucoma patients.
Receives: Device: IPL
Control groupNo interventionThe control group received no treatment

What is being measured

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

  1. Non-invasive tear break-up time

    Changes in non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer.

    Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.

    Measured: Day-0 (baseline), 2-week, 4-weeks

Secondary outcomes (6)

  1. Conjunctival hyperemia (RS score)

    Conjunctival hyperemia (RS score) will be assessed by keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 to 4.0.

    Measured: Day-0 (baseline), 2-week, 4-weeks

  2. Quality of meibum grade

    Meibum quality will be assessed under a slit-lamp:

    Five meibomian gland in the middle parts of the eyelid will be assessed using a scale of 0 to 3 for each gland (0 represented clear meibum; 1 represented cloudy meibum; 2 represented cloudy and granular meibum; and 3 represented thick, toothpaste like consistency meibum).

    Measured: Day-0 (baseline), 2-week, 4-weeks

  3. Expressibility of meibum grade

    Meibum expressibility will be assessed under a slit-lamp:

    Eight meibomian glands in the middle part will be evaluated on a scale of 0 to 3 (0 denoted that all glands expressible; 1 denoted that 3 to 4 glands expressible; 2 denoted those 1 to 2 glands expressible; and 3 denoted that no glands were expressible). The overall score was computed using the mean scores of these eight glands.

    Measured: Day-0 (baseline), 2-week, 4-weeks

  4. Conjunctivocorneal epithelial staining grade

    Conjunctivocorneal epithelial staining will be assessed under a slit-lamp:

    Conjunctivocorneal epithelial staining will be assess corneal and conjunctival epithelium damage. Double vital staining approach with two microliters of a preservative-free solution containing 1% lissamine green and 1% sodium fluorescein will be instilled in the conjunctival sac.

    The eye will be sectioned into three equal pieces (temporal conjunctiva, cornea, and nasal conjunctiva). Each region receives a maximum staining score of three points and a minimum of zero points. The combined scores from all three parts were then recorded on a scale ranging from 0 (normal) to 9 (severe).

    Measured: Day-0 (baseline), 1-week, 2-weeks

  5. Tear Film Lipid Layer

    Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan).

    Measured: Day-0 (baseline), 2-week, 4-weeks

  6. OSDI Score

    Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will beused to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points

    Measured: Day-0 (baseline), 2-week, 4-weeks

Timeline

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

  1. First posted6 Dec 2023
  2. Study start3 Oct 2023
  3. Primary completion1 Dec 2023
  4. Study completion2 Dec 2023

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 N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Prospective, comparative pilot study
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06158984
Sponsor's protocol ID
GLADQSLIP2023
Status last verified
Dec 2023
First submitted
7 Feb 2023
Last updated
27 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang H, Qi Y, Chen J, Qin G, Xu L, He W, Yu S, Che H, Pazo EE. Management of Glaucoma-Related Dry Eye Disease with Intense Pulsed Light: A Randomized Control Study. Clin Ophthalmol. 2024 Jul 15;18:2061-2072. doi: 10.2147/OPTH.S471426. eCollection 2024.

    PubMed 39055379

Questions about this trial

What is this clinical trial studying?

A study testing IPL in people with Dry Eye, run by He Eye Hospital at 1 site in China.

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 3 inclusion and 14 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: finished, as of the sponsor's last update on 27 Dec 2023. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-invasive tear break-up time (time frame: Day-0 (baseline), 2-week, 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 NCT06158984, which also lists 1 linked publication.

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 27 Dec 2023.

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