Erosion; Cornea, TraumaticPhase 3NCT01809483
Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients
A Phase 3 study testing Bandage contact lens and Pressure patching in people with Erosion; Cornea, Traumatic, run by Udayana University at 1 site in Indonesia.
Trial summary
This research aims to compare between bandage contact lens and pressure patching in reducing size of erosion area and pain scale in corneal erosion patients as well as its complications. Read more about this study
- Who is it for?
- Ages 17 to 55 years
- Conditions the study is for
- Erosion; Cornea, Traumatic
- What is being tested?
- Bandage contact lens and Pressure patching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- Sep 2012to Feb 2013
- 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 17 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- aged 17-55 years
- onset of corneal erosion < 48 hours
- corneal erosion due to mechanical injury
- extensive corneal erosion > 3 mm2
Who cannot join
- bilateral corneal erosion
- corneal erosion due to chemical or thermal injury
- history of systemic analgesic use within 1 week prior to the examination or topical analgesics within 1 hour before the examination
- history of systemic or topical antibiotics within 1 week prior to the examination
- other abnormalities due to trauma
- palpebral or eyelashes position abnormalities
- anterior segment infections
- tear break-up time < 7 seconds in the contra lateral eye
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Depatment of Ophthalmolohy, Medical Faculty, Udayana University / Sanglah Public General Hospital
Denpasar, Bali, 80114
About this study
This research aims to compare between bandage contact lens and pressure patching in reducing size of erosion area and pain scale in corneal erosion patients as well as its complications.
Read the detailed description
This is a randomized open-label clinical trial in patients with mechanical corneal erosion. Subjects were selected to use bandage contact lens (Senofilcon A) or pressure patching. All subjects received combination of Polymyxin B, Neomycin, and Gramicidin eye drops and 0,5% Tropicamide eye drops. Evaluation was done 24 hours after treatment
- Conditions
- Erosion; Cornea, Traumatic
- Being tested
- Bandage contact lens, Pressure patching
- Keywords
- mechanical corneal erosion, bandage contact lens, pressure patching, erosion area, pain scale
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bandage contact lensDevice
Bandage contact lens : contact lenses (material senofilcon A; base curve 8,8 mm; power - 0,50; diameter 14 mm)
Pressure patchingDevice
Pressure patching : using 2 pieces of sterile gauze. The first gauze placed vertically and the second placed horizontally, then fixed with adhesive tape so that eyelid can not move.
| Study group | Role | What they receive |
|---|---|---|
| Bandage contact lens group | Experimental | subject received antibiotic eye drops (combination of Polymyxin B, neomycin and gramicidin, q.i.d), and cycloplegic eye drops (tropicamide 0,5 %, q.d) and bandage contact lens. Bandage contact lenses maintained for 24 hours. Antibiotic eye drops were instilled without removing the contact lenses Receives: Device: Bandage contact lens |
| Pressure patching group | Active comparator | Subject received antibiotic eye drops (combination of Polymyxin B, neomycin and gramicidin, q.i.d), and cycloplegic eye drops (tropicamide 0,5 %, q.d) and pressure patching. Pressure patching maintained for 24 hours and only opened for drug application. Subject and their families were educated on how to perform a good pressure patching Receives: Device: Pressure patching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of corneal erosion area
Corneal erosion area is the multiplication of the long and short axis of corneal erosion, as measured using a caliper, with the help of fluorescein and cobalt blue slit lamp beam
Measured: 24 hour
Secondary outcomes (1)
Pain scale
Pain scale assessment conducted using the Visual Analogue Scale (VAS) subjectively
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosion; Cornea, TraumaticStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Udayana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ni Nyoman Triharpini, Udayana University
- Investigators
- Ni Nyoman Triharpini, MD, Principal investigator, Department of Ophthalmology, Medical Faculty Udayana University / Sanglah Public General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809483
- Sponsor's protocol ID
- LB0201/IIC5D11/16095/2012
- Status last verified
- Mar 2013
- First submitted
- 8 Mar 2013
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Bandage Contact Lens and Pressure Patching for The Erosion Area and Pain Scale in Corneal Erosion Patients
- ClinicalTrials.gov ID
- NCT01809483
- Acronym / sponsor ID
- LB0201/IIC5D11/16095/2012
- Conditions
- Erosion; Cornea, Traumatic
- Keywords
- mechanical corneal erosion, bandage contact lens, pressure patching, erosion area, pain scale
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Udayana UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 12 Mar 2013 (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.
This research aims to compare between bandage contact lens and pressure patching in reducing size of erosion area and pain scale in corneal erosion patients as well as its complications.
Detailed description
This is a randomized open-label clinical trial in patients with mechanical corneal erosion. Subjects were selected to use bandage contact lens (Senofilcon A) or pressure patching. All subjects received combination of Polymyxin B, Neomycin, and Gramicidin eye drops and 0,5% Tropicamide eye drops. Evaluation was done 24 hours after treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bandage contact lens group | Experimental | Device: Bandage contact lenssubject received antibiotic eye drops (combination of Polymyxin B, neomycin and gramicidin, q.i.d), and cycloplegic eye drops (tropicamide 0,5 %, q.d) and bandage contact lens. Bandage contact lenses maintained for 24 hours. Antibiotic eye drops were instilled without removing the contact lenses |
| Pressure patching group | Active comparator | Device: Pressure patchingSubject received antibiotic eye drops (combination of Polymyxin B, neomycin and gramicidin, q.i.d), and cycloplegic eye drops (tropicamide 0,5 %, q.d) and pressure patching. Pressure patching maintained for 24 hours and only opened for drug application. Subject and their families were educated on how to perform a good pressure patching |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- aged 17-55 years
- onset of corneal erosion < 48 hours
- corneal erosion due to mechanical injury
- extensive corneal erosion > 3 mm2
Key exclusion criteria (8 listed)
- bilateral corneal erosion
- corneal erosion due to chemical or thermal injury
- history of systemic analgesic use within 1 week prior to the examination or topical analgesics within 1 hour before the examination
- history of systemic or topical antibiotics within 1 week prior to the examination
- other abnormalities due to trauma
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 |
|---|---|---|
| Bandage contact lensBandage contact lens : contact lenses (material senofilcon A; base curve 8,8 mm; power - 0,50; diameter 14 mm) | Device | Bandage contact lens group |
| Pressure patchingPressure patching : using 2 pieces of sterile gauze. The first gauze placed vertically and the second placed horizontally, then fixed with adhesive tape so that eyelid can not move. | Device | Pressure patching group |
Primary outcome
Size of corneal erosion area
Time frame: 24 hour
Corneal erosion area is the multiplication of the long and short axis of corneal erosion, as measured using a caliper, with the help of fluorescein and cobalt blue slit lamp beam
1 secondary outcome
Pain scale
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
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.
Ni Nyoman Triharpini, MD principal investigator
Department of Ophthalmology, Medical Faculty Udayana University / Sanglah Public General Hospital
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 Bandage contact lens and Pressure patching in people with Erosion; Cornea, Traumatic, run by Udayana University at 1 site in Indonesia.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 12 Mar 2013. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of corneal erosion area (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2013.