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

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

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.

Study Overview

• Status: Unknown
• Conditions: Age-related Cataract
• Intervention / Treatment: Drug: Hylo-Comod eye drop; Drug: Tears Naturale Forte eye drop

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hainan
    • Haikou, Hainan, China, 570311
      • Recruiting
      • Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 0.3% tobramycin/dexamethasone (TobraDex, Alcon)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
scale of Schirmer I test	up to 2 months after surgery
scale of corneal fluorescein staining	up to 2 months after surgery
scale of noninvasive tear breakup time	up to 2 months after surgery
questionnaire of ocular surface disease index	up to 2 months after surgery
scale of central corneal sensitivity	up to 2 months after surgery
scale of tear meniscus height	up to 2 months after surgery
concentration of Interleukin-1α	up to 2 months after surgery
concentration of tumor necrosis factor-α	up to 2 months after surgery
concentration of nerve growth factor	up to 2 months after surgery
concentration of interferon-γ	up to 2 months after surgery
concentration of transforming growth factor-β1	up to 2 months after surgery
concentration of matrix metalloproteinase-9	up to 2 months after surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation Between Inflammatory Mediators and Ocular Surface Changes	up to 2 months after surgery

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Principal Investigator: Xingwu Zhong, MD, PhD, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: June 26, 2016
• First Submitted That Met QC Criteria: June 26, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Estimate): November 28, 2016
• Last Update Submitted That Met QC Criteria: November 24, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: phacoemulsification; inflammatory mediators; age-related cataract; Holy-Comod; Tears Naturale Forte
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Adrenergic Agonists; Anti-Bacterial Agents; Pharmaceutical Solutions; Dexamethasone; Dexamethasone acetate; BB 1101; Ophthalmic Solutions; Tobramycin; Tobramycin, Dexamethasone Drug Combination; Dipivefrin
• Other Study ID Numbers: 2016-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No