Clinical trial

Management of Dry Eye With Intense Pulsed Light in Combination With Diquafosol

Name
IPLDQS2023
Description
Intense pulsed light (IPL) has been reported to improve signs and symptoms of dry eye (DE). Additionally, meibomian gland secretion of lipids has been observed to improve through the use of IPL. Diquafosol ophthalmic solution (DQS) stimulates P2Y2 receptors on the ocular surface, which enhances mucin secretion from goblet cells. Therefore, tear film stability and hydration of the ocular surface can be achieved independent from lacrimal glands function. The purpose of this prospective study was to evaluate and compare the effects of IPL (IPL group), DQS (DQS group) and IPL in combination with DQS (IPL+ group) in participants with persistent DE. Tear film lipid layer (TFLL), non-invasive breakup time (NITBUT), tear meniscus height (TMH), corneoconjunctival staining score (CS), meibum gland (MG) function, conjunctival hyperemia (RS score), ocular surface disease index (OSDI) will be assessed and compared at baseline, day-14, and day-28.
Trial arms
Trial start
2023-03-01
Estimated PCD
2023-07-01
Trial end
2023-07-01
Status
Completed
Treatment
Intense pulsed light
IPL treatment intensity was chosen based on the Fitzpatrick scale as follows: Fitzpatrick scale I, II, III, 10-15 J/cm2 with a 570-nm filter.
Arms:
IPL, IPL+
Other names:
IPL
Diquafosol tetrasodium
3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in dry eye signs and symptoms
Arms:
DQS, IPL+
Other names:
Diquas
Size
360
Primary endpoint
Non-invasive tear break-up time (NIBUT)
Day-0 (baseline), day-14 and day-28
Ocular Surface Disease Index (OSDI)
Day-0 (baseline), day-14 and day-28
Eligibility criteria
Inclusion Criteria: * Age ≥18 years * Consenting participants * Able and willing to comply with the treatment/follow-up schedule * Bilateral signs and symptoms of dry eye disease: (i) Ocular Surface Disease Index (OSDI) questionnaire ≥13, (ii) Non-invasive tear break-up (NITBUT) ≤ 5 seconds, (iii) conjunctival staining score (CS) ≥3 points. The presence of two or more criteria was used to establish a positive DE diagnosis based on the 2016 Asia Dry Eye Society criteria Exclusion Criteria: * A recent history (past 30 days) of topical ophthalmic medication use, including antibiotics, steroids, non-steroidal anti-inflammatory drugs, or required the chronic use of topical ophthalmic medications. * Eyelids or intraocular tumors. * Active allergy or infection, or inflammatory disease may prevent the subjects from completing the study at the ocular surface. * Any structural changes in the lacrimal passage * Glaucoma * Diabetes or other systemic, dermatologic, or neurologic diseases that affect the health of the ocular surface. * Use of any systemic anti-inflammatory drugs or medication that may interfere with tear production, such as antianxiety, anti-depressive, and antihistamine medications, within three months. * Pregnancy or breastfeeding * Contact lenses wearers.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'Masked examiner for all clinical assessments will not involved in the data collection or group allocation procedure for this research. The investigator will not be aware of the three groups.', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 360, 'type': 'ACTUAL'}}
Updated at
2023-07-25

1 organization

1 product

1 indication

Organization
He Eye Hospital
Product
Diquafosol
Indication
Dry Eye