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Completed

NCT Number: NCT06158984

Managing Dry Eye in Patients Using Glaucoma Drops

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

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Glaucoma Lacrimal Apparatus Diseases Ocular Hypertension

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

He Eye Hospital

Shenyang, Liaoning, 110001, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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
  • Pterygium
  • Corneal neovascularization
  • Breastfeeding
  • Rheumatic immune systemic diseases
  • Herpes zoster infection
  • Pregnant women
  • Allergic to fluorescein
  • Contact lens wearers

Treatment and study plan

IPL

Device

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

Other names: Intense pulsed light

Primary outcomes

  1. Non-invasive tear break-up time

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

    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.

Secondary outcomes

  1. Conjunctival hyperemia (RS score)

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

    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.

  2. Quality of meibum grade

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

    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).

  3. Expressibility of meibum grade

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

    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.

  4. Conjunctivocorneal epithelial staining grade

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

    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).

  5. Tear Film Lipid Layer

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

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

  6. OSDI Score

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

    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

Sponsors and collaborators

Lead sponsor

He Eye Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 6, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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