Managing Dry Eye in Patients Using Glaucoma Drops

Dry Eye Clinical Trial

Official title:

Managing Dry Eye in Patients Using Glaucoma Drops

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06158984
• Other study ID #: GLADQSLIP2023
• Status: Completed
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: December 2, 2023

Study information

• Verified date: December 2023
• Source: He Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Glaucoma
• Keratoconjunctivitis Sicca

Intervention

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

Locations

Country	Name	City	State
China	He Eye Hospital	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
He Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day-0 (baseline), 2-week, 4-weeks
Secondary	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.	Day-0 (baseline), 2-week, 4-weeks
Secondary	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).	Day-0 (baseline), 2-week, 4-weeks
Secondary	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.	Day-0 (baseline), 2-week, 4-weeks
Secondary	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).	Day-0 (baseline), 1-week, 2-weeks
Secondary	Tear Film Lipid Layer	Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan).	Day-0 (baseline), 2-week, 4-weeks
Secondary	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	Day-0 (baseline), 2-week, 4-weeks