NCT02817191

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

June 26, 2016

Last Update Submit

November 24, 2016

Conditions

Age-related Cataract

Keywords

age-related cataractHoly-ComodTears Naturale Fortephacoemulsificationinflammatory mediators

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (1)

  • Correlation Between Inflammatory Mediators and Ocular Surface Changes

    up to 2 months after surgery

Study Arms (2)

Hylo-Comod

EXPERIMENTAL

The patients used Hylo-Comod eye drop after phaco+IOL in this group.

Drug: Hylo-Comod eye drop

Tears Naturale Forte

EXPERIMENTAL

The patients used Tears Naturale Forte eye drop after phaco+IOL in this group.

Drug: Tears Naturale Forte eye drop

Interventions

Hylo-Comod eye dropDRUG

The patients were administrated Hylo-Comod eye drop four times a day after Phaco+IOL

Also known as: 0.3% tobramycin/dexamethasone (TobraDex, Alcon)
Hylo-Comod
Tears Naturale Forte eye dropDRUG

The patients were administrated Tears Naturale Forte eye drop four times a day after Phaco+IOL

Also known as: 0.3% tobramycin/dexamethasone (TobraDex, Alcon)
Tears Naturale Forte

Eligibility Criteria

Age60 Years - 72 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • classification of lens nucleus is LOCS Ⅱ

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hainan Eye Hospital, Zhongshan Ophthalmic Center of Sun Yat-sen University

Haikou, Hainan, 570311, China

RECRUITING

MeSH Terms

Interventions

TobramycinDexamethasoneTobramycin, Dexamethasone Drug Combinationmethylacetylene

Intervention Hierarchy (Ancestors)

NebramycinKanamycinAminoglycosidesGlycosidesCarbohydratesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedDrug CombinationsPharmaceutical Preparations

Study Officials

  • Xingwu Zhong, MD, PhD

    Zhongshan Ophthalmic Center, Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

CHI ZHANG, MD, PhD

CONTACT

+8613790077756mike0946@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2016

First Posted

June 29, 2016

Study Start

June 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

CN(1)