Dry Eye Symptom Mitigation by Oral Intake of Probiotics

Dry Eye Clinical Trial

Official title:

A Clinical Trial of Dry Eye Symptom Mitigation by Oral Intake of Probiotics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05906381
• Other study ID #: 202300014B0
• Status: Recruiting
• Phase: N/A
• Start date: May 13, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Chung Shan Medical University
• Contact: David Pei-Cheng Lin
• Phone: 886-910-371286
• Email: pcl[@]csmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates whether the oral intake of a probiotics capsule product may relieve dry eye symptoms. Participants will be aged between 20 - 65 years of age, with confirmed diagnosis of dry eye status. The participants will be assessed for several parameters and asked to take 1 probiotics capsule per day for 35 days. The parameters will include ocular surface health, tear volume, tear quality, intraocular pressure, tear osmolarity and serum biochemical test. After the 35 days are completed, the participants will be assessed again for the same parameters.

Description:

This investigation is a randomized, double-blind study. Subjects with confirmed diagnosis of dry eye are randomly assigned to control group or treatment group, and asked to orally intake 1 capsule of either placebo or probiotics per day. All participants will be assessed for parameters, including intraocular pressure, ocular surface health, tear film breakup time (TBUT), tear volume (Schirmer's test), tear osmolarity, ocular surface impression cytology, ocular surface disease index (OSDI) and serum biochemical tests for quantification of hyaluronic acid, sialic acid, glutathione contents.The assessments are conducted at day1 for baseline and after the 35-day oral intake. The parameters are used to compare and evaluate whether the probiotics can relieve dry eye symptoms.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• aged between 20 and 65 years

• with Schirmer's test results less than 10 mm or Ocular Surface Disease Index more than 25

Exclusion Criteria:

• evident ocular diseases such as cornea disease, cataract, vitreous degeneration, glaucoma, and retinopathy.

• diabetes

• hypertension

• or other chronic diseases or belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Dietary Supplement:
• Probiotics
A specific probiotics capsule product, containing Streptococcus thermophilus will be given to participants for oral intake for 35 days.
• Placebo
A specific capsule product, containing microcrystalline cellulose will be given to participants for oral intake for 35 days.

Locations

Country	Name	City	State
Taiwan	Jen-Ai Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
Chung Shan Medical University	Nutrarex Biotech Co., Ltd.

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

Brito-Zeron P, Ramos-Casals M; EULAR-SS task force group. Advances in the understanding and treatment of systemic complications in Sjogren's syndrome. Curr Opin Rheumatol. 2014 Sep;26(5):520-7. doi: 10.1097/BOR.0000000000000096. — View Citation

Chisari G, Chisari EM, Francaviglia A, Chisari CG. The mixture of bifidobacterium associated with fructo-oligosaccharides reduces the damage of the ocular surface. Clin Ter. 2017 May-Jun;168(3):e181-e185. doi: 10.7417/T.2017.2002. — View Citation

Fox RI, Chan R, Michelson JB, Belmont JB, Michelson PE. Beneficial effect of artificial tears made with autologous serum in patients with keratoconjunctivitis sicca. Arthritis Rheum. 1984 Apr;27(4):459-61. doi: 10.1002/art.1780270415. No abstract available. — View Citation

Herrero-Vanrell R, Peral A. [International Dry Eye Workshop (DEWS). Update of the disease]. Arch Soc Esp Oftalmol. 2007 Dec;82(12):733-4. doi: 10.4321/s0365-66912007001200002. No abstract available. Spanish. — View Citation

Schrader S, Mircheff AK, Geerling G. Animal models of dry eye. Dev Ophthalmol. 2008;41:298-312. doi: 10.1159/000131097. — View Citation

Sullivan DA, Krenzer KL, Sullivan BD, Tolls DB, Toda I, Dana MR. Does androgen insufficiency cause lacrimal gland inflammation and aqueous tear deficiency? Invest Ophthalmol Vis Sci. 1999 May;40(6):1261-5. — View Citation

Wilson WS, Duncan AJ, Jay JL. Effect of benzalkonium chloride on the stability of the precorneal tear film in rabbit and man. Br J Ophthalmol. 1975 Nov;59(11):667-9. doi: 10.1136/bjo.59.11.667. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Schirmer's Test Value from Baseline	The Schirmer's Test is used to assess tear secretion volume. The amounts of tears are measured in total millimeters after 5 minutes has elapsed. Lower measurement amount is regarded as a parameter of presence of dry eye disease.	on baseline and day36
Primary	Change of Tear Film Breakup Time from Baseline	Tear Break-Up Time is a measurement to reflect tear quality and is expressed in seconds. The shorter the Tear Break-Up Time, the poorer the tear film stability and quality. Lower measurement outcome (less than 10 seconds) is regarded as a parameter of presence of dry eye disease.	on baseline and day36
Primary	Ocular Surface Index Change from Baseline	Ocular Surface Index is assessed with fluorescein staining to reflect ocular surface damages. The staining scale ranges from 0 to 3, from milder to severe status, where grade 0 shows no staining, and grade 3 shows extensive staining.	on baseline and day36
Primary	Tear Osmolality Change from Baseline	Tear osmolality is used as a parameter of dry eye status.	on baseline and day36
Primary	Serum Biochemical Test	To determine the effects of oral probiotics intake on the contents of hyaluronic acid, sialic acid, and glutathione in the serum.	on baseline and day36
Secondary	Ocular Surface Impression Cytology Change from Baseline	To assess the status of conjunctival goblet cells and epithelium.	on baseline and day36
Secondary	Ocular Surface Disease Index Score Change from Baseline	A questionnaire is used to assess the health status on ocular surface, with higher scores indicating more severe status.	on baseline and day36
Secondary	Intraocular Pressure Change from Baseline	To determine the effects of intervention on intraocular pressure.	on baseline and day36