Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02817191
Recruitment Status : Unknown
Verified November 2016 by Xingwu Zhong, MD PhD, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : June 29, 2016
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Xingwu Zhong, MD PhD, Sun Yat-sen University

Brief 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.

Condition or disease Intervention/treatment Phase
Age-related Cataract Drug: Hylo-Comod eye drop Drug: Tears Naturale Forte eye drop Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Holy-Comod and Tears Naturale Forte on Ocular Surface and Tear Inflammatory Mediators in Patients After Phaco+IOL
Study Start Date : June 2016
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Arm Intervention/treatment
Experimental: Hylo-Comod
The patients used Hylo-Comod eye drop after phaco+IOL in this group.
Drug: Hylo-Comod eye drop
The patients were administrated Hylo-Comod eye drop four times a day after Phaco+IOL
Other Name: 0.3% tobramycin/dexamethasone (TobraDex, Alcon)

Experimental: Tears Naturale Forte
The patients used Tears Naturale Forte eye drop after phaco+IOL in this group.
Drug: Tears Naturale Forte eye drop
The patients were administrated Tears Naturale Forte eye drop four times a day after Phaco+IOL
Other Name: 0.3% tobramycin/dexamethasone (TobraDex, Alcon)




Primary Outcome Measures :
  1. scale of Schirmer I test [ Time Frame: up to 2 months after surgery ]
  2. scale of corneal fluorescein staining [ Time Frame: up to 2 months after surgery ]
  3. scale of noninvasive tear breakup time [ Time Frame: up to 2 months after surgery ]
  4. questionnaire of ocular surface disease index [ Time Frame: up to 2 months after surgery ]
  5. scale of central corneal sensitivity [ Time Frame: up to 2 months after surgery ]
  6. scale of tear meniscus height [ Time Frame: up to 2 months after surgery ]
  7. concentration of Interleukin-1α [ Time Frame: up to 2 months after surgery ]
  8. concentration of tumor necrosis factor-α [ Time Frame: up to 2 months after surgery ]
  9. concentration of nerve growth factor [ Time Frame: up to 2 months after surgery ]
  10. concentration of interferon-γ [ Time Frame: up to 2 months after surgery ]
  11. concentration of transforming growth factor-β1 [ Time Frame: up to 2 months after surgery ]
  12. concentration of matrix metalloproteinase-9 [ Time Frame: up to 2 months after surgery ]

Secondary Outcome Measures :
  1. Correlation Between Inflammatory Mediators and Ocular Surface Changes [ Time Frame: up to 2 months after surgery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 60-72 years old
  • classification of lens nucleus is LOCS Ⅱ

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817191


Contacts
Layout table for location contacts
Contact: CHI ZHANG, MD, PhD +8613790077756 mike0946@163.com

Locations
Layout table for location information
China, Hainan
Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University Recruiting
Haikou, Hainan, China, 570311
Contact: Xingwu Zhong, MD,PhD    +86(898)68628481    zhongxwu@mail.sysu.edu.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Layout table for investigator information
Principal Investigator: Xingwu Zhong, MD, PhD Zhongshan Ophthalmic Center, Sun Yat-sen University

Layout table for additonal information
Responsible Party: Xingwu Zhong, MD PhD, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02817191     History of Changes
Other Study ID Numbers: 2016-005
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016

Keywords provided by Xingwu Zhong, MD PhD, Sun Yat-sen University:
age-related cataract
Holy-Comod
Tears Naturale Forte
phacoemulsification
inflammatory mediators

Additional relevant MeSH terms:
Layout table for MeSH terms
Cataract
Lens Diseases
Eye Diseases
Dexamethasone
Dexamethasone acetate
Tobramycin, Dexamethasone Drug Combination
BB 1101
Ophthalmic Solutions
Tobramycin
Dextrans
Glycerol
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmaceutical Solutions
Anti-Bacterial Agents
Anti-Infective Agents
Anticoagulants
Plasma Substitutes