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Age-related CataractNCT02817191

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

A study testing Hylo-Comod eye drop and Tears Naturale Forte eye drop in people with Age-related Cataract, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 60 to 72 yearsHealthy volunteers can take part
Conditions the study is for
Age-related Cataract
What is being tested?
Hylo-Comod eye drop and Tears Naturale Forte eye drop
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
Jun 2016to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 72 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

CHI ZHANG, MD, PhD contact

+8613790077756

mike0946@163.com

China1 site, 1 recruiting

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

    Haikou, Hainan, 570311

    Xingwu Zhong, MD,PhD, +86(898)68628481, zhongxwu@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
Hylo-Comod eye drop, Tears Naturale Forte eye drop
Keywords
age-related cataract, Holy-Comod, Tears Naturale Forte, phacoemulsification, inflammatory mediators

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hylo-Comod eye dropDrug

    Also called 0.3% tobramycin/dexamethasone (TobraDex, Alcon)

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

  • Tears Naturale Forte eye dropDrug

    Also called 0.3% tobramycin/dexamethasone (TobraDex, Alcon)

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

Study groups in NCT02817191
Study groupRoleWhat they receive
Hylo-ComodExperimentalThe patients used Hylo-Comod eye drop after phaco+IOL in this group.
Receives: Drug: Hylo-Comod eye drop
Tears Naturale ForteExperimentalThe patients used Tears Naturale Forte eye drop after phaco+IOL in this group.
Receives: Drug: Tears Naturale Forte eye drop

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. scale of Schirmer I test

    Measured: up to 2 months after surgery

  2. scale of corneal fluorescein staining

    Measured: up to 2 months after surgery

  3. scale of noninvasive tear breakup time

    Measured: up to 2 months after surgery

  4. questionnaire of ocular surface disease index

    Measured: up to 2 months after surgery

  5. scale of central corneal sensitivity

    Measured: up to 2 months after surgery

  6. scale of tear meniscus height

    Measured: up to 2 months after surgery

  7. concentration of Interleukin-1α

    Measured: up to 2 months after surgery

  8. concentration of tumor necrosis factor-α

    Measured: up to 2 months after surgery

  9. concentration of nerve growth factor

    Measured: up to 2 months after surgery

  10. concentration of interferon-γ

    Measured: up to 2 months after surgery

  11. concentration of transforming growth factor-β1

    Measured: up to 2 months after surgery

  12. concentration of matrix metalloproteinase-9

    Measured: up to 2 months after surgery

Secondary outcomes (1)

  1. Correlation Between Inflammatory Mediators and Ocular Surface Changes

    Measured: up to 2 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionNov 2016
  4. Study completionNov 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02817191
Sponsor's protocol ID
2016-005
Status last verified
Nov 2016
First submitted
26 Jun 2016
Last updated
28 Nov 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Hylo-Comod eye drop and Tears Naturale Forte eye drop in people with Age-related Cataract, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact CHI ZHANG, MD, PhD (+8613790077756, mike0946@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

scale of Schirmer I test (time frame: up to 2 months after surgery). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02817191.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2016.

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