Effects of Holy-Comod and Tears Naturale Forte in Patients After Phaco+IOL

Age-related Cataract Clinical Trial

Official title:

Effects of Holy-Comod and Tears Naturale Forte on Ocular Surface and Tear Inflammatory Mediators in Patients After Phaco+IOL

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02817191
• Other study ID #: 2016-005
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2016
• Last updated: November 24, 2016
• Start date: June 2016
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Sun Yat-sen University
• Contact: CHI ZHANG, MD, PhD
• Phone: +8613790077756
• Email: mike0946[@]163.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

The purpose of the study it to compare the effects of Holy-Comod and Tears Naturale Forte on ocular surface and tear inflammatory mediators in patients after Phaco+IOL.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 72 Years

Eligibility

Inclusion Criteria:

• 60-72 years old

• classification of lens nucleus is LOCS ?

Exclusion Criteria:

• patients with previous history of ocular surgery, corneal diseases,uveitis ,ocular hypertension or glaucoma ,systemic diseases.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-related Cataract
• Cataract

Intervention

Drug:
• Hylo-Comod eye drop
The patients were administrated Hylo-Comod eye drop four times a day after Phaco+IOL
• Tears Naturale Forte eye drop
The patients were administrated Tears Naturale Forte eye drop four times a day after Phaco+IOL

Locations

Country	Name	City	State
China	Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University	Haikou	Hainan

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scale of Schirmer I test		up to 2 months after surgery	No
Primary	scale of corneal fluorescein staining		up to 2 months after surgery	No
Primary	scale of noninvasive tear breakup time		up to 2 months after surgery	No
Primary	questionnaire of ocular surface disease index		up to 2 months after surgery	No
Primary	scale of central corneal sensitivity		up to 2 months after surgery	No
Primary	scale of tear meniscus height		up to 2 months after surgery	No
Primary	concentration of Interleukin-1a		up to 2 months after surgery	No
Primary	concentration of tumor necrosis factor-a		up to 2 months after surgery	No
Primary	concentration of nerve growth factor		up to 2 months after surgery	No
Primary	concentration of interferon-?		up to 2 months after surgery	No
Primary	concentration of transforming growth factor-ß1		up to 2 months after surgery	No
Primary	concentration of matrix metalloproteinase-9		up to 2 months after surgery	No
Secondary	Correlation Between Inflammatory Mediators and Ocular Surface Changes		up to 2 months after surgery	No