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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02817191
Other study ID # 2016-005
Secondary ID
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


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
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