Myopes Who Have Undergone PRK.Phase 3NCT01761071

Time Serial Analysis on Preemptive Analgesia of Preoperative Topical Diclofenac and Ketorolac in Photorefractive Keratectomy(PRK)

A Phase 3 study testing topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) and topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland) in people with Myopes Who Have Undergone PRK., run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators performed this study to investigate pain prevention of preoperative topical nonsteroidal anti-inflammatory drug (NSAID) in photorefractive keratectomy(PRK) using time serial pain scoring. Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Myopes Who Have Undergone PRK.
What is being tested?: topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) and topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 1 siteSouth Korea
Study dates: Jan 2012to Dec 2012
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 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

at least 19 years of age
simultaneous bilateral PRK schedule
more than 400μm(including epithelium) of postoperative corneal thickness
less than 150μm of ablation depth.

Who cannot join

a history of ocular surgery or trauma
two-diopter more difference in spherical equivalent (SE) between the eyes, 3. keratoconus or other corneal pathology
4. use of systemic or topical NSAID within 1 month before the surgery 5. history of allergic reaction to aspirin or other NSAIDs 6. glaucoma or ocular hypertension (> 20 mmHg) 7. collagen vascular diseases 8. diabetic retinopathy 9. pregnancy or lactation 10. intraoperative complications.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Departement of Ophthalmology, Yonsei University College of Medicine
Seoul, Seoul, 120-752

Other trials in South Korea

About this study

Conditions: Myopes Who Have Undergone PRK.
Being tested: topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA), topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)

What participants receive

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

topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA)Drug
On operation day, the patients were randomly assigned to one of the following two groups: group KO,preoperative application of topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) in one eye and topical ofloxacin 0.3% (Ocuflox®, SamilInc, Seoul, Korea)in the other eye; group DO, topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland) in one eye and ofloxacin 0.3% in the other eye. Neither the surgeon nor the participants knew which ophthalmic would go to which eye. A randomly assigned ophthalmic was instilled into right eye first three times by 1 minute interval 30 minutes prior to operation and the other ophthalmic was instilled into left eye with the same manner 10 minute later.
topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)Drug
On operation day, the patients were randomly assigned to one of the following two groups: group KO,preoperative application of topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) in one eye and topical ofloxacin 0.3% (Ocuflox®, SamilInc, Seoul, Korea)in the other eye; group DO, topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland) in one eye and ofloxacin 0.3% in the other eye. Neither the surgeon nor the participants knew which ophthalmic would go to which eye. A randomly assigned ophthalmic was instilled into right eye first three times by 1 minute interval 30 minutes prior to operation and the other ophthalmic was instilled into left eye with the same manner 10 minute later.

Study groups in NCT01761071
Study group	Role	What they receive
group KO	Experimental	(ketorolac 0.5% in one eye, ofloxacin 0.3% in the other eye) Receives: Drug: topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA)
group DO	Active comparator	(diclofenac 0.1% in one eye, ofloxacin 0.3% in the other eye) Receives: Drug: topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)

What is being measured

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

Pain score using visual analog scale(VAS) of each topical NSAIDs pre-treated eyes.
Through these postoperative pain score which rated time serially, the effect of pre-treated topical NSAIDs(ketorolac and diclofenac) could be investigated on relieving postoperative pain after PRK.
Measured: Change the VAS level at 6, 18, 24, 36, 48, 72, and 96 hours after ketorolac in photorefractive keratectomy(PRK)

Timeline

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

Jan 2012Dec 2012

First posted4 Jan 2013 (estimated)
Study startJan 2012
Primary completionNov 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Myopes Who Have Undergone PRK.Studies of the same condition, open and under way.
More trials run by Yonsei UniversityThe sponsor's other registered studies.
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: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01761071
Sponsor's protocol ID: 4-2012-0440
Status last verified: Jan 2013
First submitted: 31 Dec 2012
Last updated: 4 Jan 2013
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 4 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Time Serial Analysis on Preemptive Analgesia of Preoperative Topical Diclofenac and Ketorolac in Photorefractive Keratectomy(PRK)
ClinicalTrials.gov ID: NCT01761071
Acronym / sponsor ID: 4-2012-0440
Conditions: Myopes Who Have Undergone PRK.
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: Yonsei UniversityUniversity, hospital or other
Study start: Jan 2012
Primary completion: Nov 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 4 Jan 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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
group KO	Experimental	Drug: topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA)(ketorolac 0.5% in one eye, ofloxacin 0.3% in the other eye)
group DO	Active comparator	Drug: topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)(diclofenac 0.1% in one eye, ofloxacin 0.3% in the other eye)

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

at least 19 years of age
simultaneous bilateral PRK schedule
more than 400μm(including epithelium) of postoperative corneal thickness
less than 150μm of ablation depth.

Key exclusion criteria (3 listed)

a history of ocular surgery or trauma
two-diopter more difference in spherical equivalent (SE) between the eyes, 3. keratoconus or other corneal pathology
4. use of systemic or topical NSAID within 1 month before the surgery 5. history of allergic reaction to aspirin or other NSAIDs 6. glaucoma or ocular hypertension (> 20 mmHg) 7. collagen vascular diseases 8. diabetic retinopathy 9. pregnancy or lactation 10. intraoperative complications.

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
topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA)On operation day, the patients were randomly assigned to one of the following two groups: group KO,preoperative application of topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) in one eye and topical ofloxacin 0.3% (Ocuflox®, SamilInc, Seoul, Korea)in the other eye; group DO, topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland) in one eye and ofloxacin 0.3% in the other eye. Neither the surgeon nor the participants knew which ophthalmic would go to which eye. A randomly assigned ophthalmic was instilled into right eye first three times by 1 minute interval 30 minutes prior to operation and the other ophthalmic was instilled into left eye with the same manner 10 minute later.	Drug	group KO
topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)On operation day, the patients were randomly assigned to one of the following two groups: group KO,preoperative application of topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) in one eye and topical ofloxacin 0.3% (Ocuflox®, SamilInc, Seoul, Korea)in the other eye; group DO, topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland) in one eye and ofloxacin 0.3% in the other eye. Neither the surgeon nor the participants knew which ophthalmic would go to which eye. A randomly assigned ophthalmic was instilled into right eye first three times by 1 minute interval 30 minutes prior to operation and the other ophthalmic was instilled into left eye with the same manner 10 minute later.	Drug	group DO

Primary outcome

Pain score using visual analog scale(VAS) of each topical NSAIDs pre-treated eyes.
Time frame: Change the VAS level at 6, 18, 24, 36, 48, 72, and 96 hours after ketorolac in photorefractive keratectomy(PRK)
Through these postoperative pain score which rated time serially, the effect of pre-treated topical NSAIDs(ketorolac and diclofenac) could be investigated on relieving postoperative pain after PRK.

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 4 Jan 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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 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: finished, as of the sponsor's last update on 4 Jan 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 South Korea. 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?

Pain score using visual analog scale(VAS) of each topical NSAIDs pre-treated eyes. (time frame: Change the VAS level at 6, 18, 24, 36, 48, 72, and 96 hours after ketorolac in photorefractive keratectomy(PRK)). 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 NCT01761071.

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 4 Jan 2013.