Corneal Epithelium ExfoliationPhase 3NCT03000556
0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation
A Phase 3 study testing 0.3% Sodium Hyaluronate Eye Drop in people with Corneal Epithelium Exfoliation, run by Fang Duan at 1 site in China.
Trial summary
Corneal abrasion (TCA) is the most common ophthalmic emergency disease, accounting for about 10% of the American ophthalmic emergency, accounting for 22% of the ophthalmic emergency in Zhongshan Ophthalmic Center. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Corneal Epithelium Exfoliation
- What is being tested?
- 0.3% Sodium Hyaluronate Eye Drop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Dec 2018
- Phase
- Phase 3
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Definitive diagnosis of primary corneal epithelial abrasion;
- Monocular onset;
- Corneal epithelium was defected and fluorescein sodium staining was positive.
Who cannot join
- Corneal epithelial defect complicated with infection
- Associated with other ocular surface disease patients (such as hypophasis, meibomian gland dysfunction, keratoconjunctivitis sicca syndrome, bullous keratopathy, corneal dystrophy and drug-induced corneal toxicity etc.)
- Pregnant or lactating women; serious heart, liver, and kidney dysfunction; mental disorders; other inflammatory or autoimmune diseases
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan ophthalmic center
Guangzhou, Guangdong, 510060
Fang Duan, 86-20-87331537, duanfangg@126.com
Zhaohui Yuan, 86-20-87331537, zhaohui1208@qq.com
About this study
Official title: 0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation After Corneal Abrasions: a Pilot Study
Corneal abrasion (TCA) is the most common ophthalmic emergency disease, accounting for about 10% of the American ophthalmic emergency, accounting for 22% of the ophthalmic emergency in Zhongshan Ophthalmic Center. Clinical emergency treatment of TCA is relatively simple and effective, corneal epithelial damage can be recovered within 48 hours. However, about 25% TCA would be developed to the recurrence of exfoliation. Once the recurrence of TCA, the treatment would be more difficult and even cause blindness. Therefore, it is of great practical significance to prevent the recurrence of TCA. However, there is no effective methods to prevent recurrence of TCA.
0.3% sodium hyaluronate eye drops can effectively supplement the shortage of tear and promote repair of corneal epithelium. On this basis, the investigators hypotheses that 0.3% sodium hyaluronate eye drops can prevent the recurrence of TCA. So, investigators intend to test effectiveness of 0.3% sodium hyaluronate drops to prevent the recurrence of TCA by a prospective, single center, randomized, controlled pilot study. In this study, 60 patients with TCA were randomly divided into control group and sodium hyaluronate treatment group and observed one year.
- Conditions
- Corneal Epithelium Exfoliation
- Being tested
- 0.3% Sodium Hyaluronate Eye Drop
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.3% Sodium Hyaluronate Eye DropDrug
The patients need to use 0.3% Sodium Hyaluronate Eye Drop for 3 month.
| Study group | Role | What they receive |
|---|---|---|
| experience | Experimental | Not described Receives: Drug: 0.3% Sodium Hyaluronate Eye Drop |
| control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence of recurrent corneal epithelium exfoliation
Recurrent corneal epithelial exfoliation was defined as positive staining of corneal fluorescein by slit lamp microscope and the patient had obvious eye pain.
Measured: 6 month
Secondary outcomes (3)
the incidence of recurrent corneal epithelium exfoliation
Recurrent corneal epithelial exfoliation was defined as positive staining of corneal fluorescein by slit lamp microscope and the patient had obvious eye pain.
Measured: 1 year
corneal fluorescein staining score
Grading of corneal epithelial fluorescein sodium staining under slit lamp. The average cornea was divided into four quadrants and scored separately, adding all the scores to get the final score. Scoring criteria: 0 point: no staining; 1 point: punctate staining less than 30 dots; 2 points: punctate staining more than 30 dots, more than the point of the color but not scattered; 3 points: severe dispersion staining but no plaque staining; 4 points: plaque staining. Maximum score of 16 points per eye.
Measured: 1 year
Corneal edema grading
Grading of corneal edema under slit lamp. 0 point: C、corneal transparency without edema; 1 point: corneal haze edema, corneal endothelium smooth, iris texture is clearly visible; 2 points: corneal surface roughness, iris texture fuzzy; 3 points: corneal endothelial surface cracking, iris texture as is not clear; 4 points: white corneal edema, intraocular structure as unclear.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Corneal Epithelium ExfoliationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fang Duan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fang Duan, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000556
- Sponsor's protocol ID
- AL-2016-DF
- Status last verified
- Dec 2016
- First submitted
- 14 Dec 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Wei M, Zou Y, Duan F, Ding X, Zhuang J, Deng J, Yuan Z. Efficacy of Long-term Use of 0.3% Sodium Hyaluronate Eye Drops for Traumatic Corneal Abrasion: A Randomized Controlled, Pilot Trial. Cornea. 2021 Oct 1;40(10):1248-1252. doi: 10.1097/ICO.0000000000002625.
PubMed 33369934
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 0.3% Sodium Hyaluronate Eye Drop to Prevent Recurrent Corneal Epithelium Exfoliation After Corneal Abrasions: a Pilot Study
- ClinicalTrials.gov ID
- NCT03000556
- Acronym / sponsor ID
- AL-2016-DF
- Conditions
- Corneal Epithelium Exfoliation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fang DuanUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Corneal abrasion (TCA) is the most common ophthalmic emergency disease, accounting for about 10% of the American ophthalmic emergency, accounting for 22% of the ophthalmic emergency in Zhongshan Ophthalmic Center. Clinical emergency treatment of TCA is relatively simple and effective, corneal epithelial damage can be recovered within 48 hours. However, about 25% TCA would be developed to the recurrence of exfoliation. Once the recurrence of TCA, the treatment would be more difficult and even cause blindness. Therefore, it is of great practical significance to prevent the recurrence of TCA. However, there is no effective methods to prevent recurrence of TCA.
0.3% sodium hyaluronate eye drops can effectively supplement the shortage of tear and promote repair of corneal epithelium. On this basis, the investigators hypotheses that 0.3% sodium hyaluronate eye drops can prevent the recurrence of TCA. So, investigators intend to test effectiveness of 0.3% sodium hyaluronate drops to prevent the recurrence of TCA by a prospective, single center, randomized, controlled pilot study. In this study, 60 patients with TCA were randomly divided into control group and sodium hyaluronate treatment group and observed one year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experience | Experimental | Drug: 0.3% Sodium Hyaluronate Eye Drop |
| control | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Definitive diagnosis of primary corneal epithelial abrasion;
- Monocular onset;
- Corneal epithelium was defected and fluorescein sodium staining was positive.
Key exclusion criteria (3 listed)
- Corneal epithelial defect complicated with infection
- Associated with other ocular surface disease patients (such as hypophasis, meibomian gland dysfunction, keratoconjunctivitis sicca syndrome, bullous keratopathy, corneal dystrophy and drug-induced corneal toxicity etc.)
- Pregnant or lactating women; serious heart, liver, and kidney dysfunction; mental disorders; other inflammatory or autoimmune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.3% Sodium Hyaluronate Eye DropThe patients need to use 0.3% Sodium Hyaluronate Eye Drop for 3 month. | Drug | experience |
Primary outcome
the incidence of recurrent corneal epithelium exfoliation
Time frame: 6 month
Recurrent corneal epithelial exfoliation was defined as positive staining of corneal fluorescein by slit lamp microscope and the patient had obvious eye pain.
3 secondary outcomes
the incidence of recurrent corneal epithelium exfoliation
Time frame: 1 year
corneal fluorescein staining score
Time frame: 1 year
Corneal edema grading
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
- Derived from this study: PubMed 33369934Wei M, Zou Y, Duan F, Ding X, Zhuang J, Deng J, Yuan Z. Efficacy of Long-term Use of 0.3% Sodium Hyaluronate Eye Drops for Traumatic Corneal Abrasion: A Randomized Controlled, Pilot Trial. Cornea. 2021 Oct 1;40(10):1248-1252. doi: 10.1097/ICO.0000000000002625.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 0.3% Sodium Hyaluronate Eye Drop in people with Corneal Epithelium Exfoliation, run by Fang Duan 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 3 inclusion and 3 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 22 Dec 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Fang Duan, doctor (8613710790313, duanfangg@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence of recurrent corneal epithelium exfoliation (time frame: 6 month). 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 NCT03000556, which also lists 1 linked publication.
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 22 Dec 2016.