Photorefractive KeratectomyPhase 4NCT00330798
A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief
A Phase 4 study testing nepafenac 0.1% and ketorolac 0.4% in people with Photorefractive Keratectomy, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to compare healing times and subjective pain level responses of nepafenac to placebo after photo refractive keratomileusis (PRK) surgery. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Photorefractive Keratectomy
- What is being tested?
- nepafenac 0.1% and ketorolac 0.4%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jun 2006
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 19 years or older with healthy ocular status and pre-operative refractive anisometropia of less than 2.000 diopters between eyes undergoing bilateral PRK surgery.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Those desiring PRK in only one eye, those in need of additional topical eye medications, those with history of drug/alcohol abuse, women breastfeeding or pregnant.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief of Patients Status Post-Photorefractive Keratectomy: A Double-Masked Randomized Prospective Study
The purpose of this study is to compare healing times and subjective pain level responses of nepafenac to placebo after photo refractive keratomileusis (PRK) surgery.
- Conditions
- Photorefractive Keratectomy
- Being tested
- nepafenac 0.1%, ketorolac 0.4%
- Keywords
- Photorefractive Keratectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nepafenac 0.1%Drug
Nepafenac 0.1% randomly assigned to one eye, with ketorolac 0.4% in the fellow eye for contralateral post-surgical use.
ketorolac 0.4%Other
Keterolac 0.4% randomly assigned to one eye, with nepafenac 0.1% in the fellow eye for contralateral post-surgical use.
| Study group | Role | What they receive |
|---|---|---|
| Nevanac | Experimental | One drop, three times daily, in the assigned eye for the first three postoperative days Receives: Drug: nepafenac 0.1% |
| Acular LS | Placebo comparator | One drop, three times daily, in the assigned eye for the first three postoperative days Receives: Other: ketorolac 0.4% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective pain
Measured: Day 5
Secondary outcomes (1)
Rate of epithelial healing
Measured: Time to event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startFeb 2006
- Primary completionJun 2006
- Study completionJun 2006
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 Photorefractive KeratectomyStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Matthew Caldwell
- Responsible party
- Sponsor
- Investigators
- Matthew Caldwell, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330798
- Sponsor's protocol ID
- FWH20060020H
- Status last verified
- May 2012
- First submitted
- 25 May 2006
- Last updated
- 18 Nov 2016
- Results posted
- No
Publications
Caldwell M, Reilly C. Effects of topical nepafenac on corneal epithelial healing time and postoperative pain after PRK: a bilateral, prospective, randomized, masked trial. J Refract Surg. 2008 Apr;24(4):377-82. doi: 10.3928/1081597X-20080401-11.
PubMed 18500088
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Topical Nepafenac to Placebo in Corneal Epithelial Healing Times and Postoperative Pain Relief of Patients Status Post-Photorefractive Keratectomy: A Double-Masked Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT00330798
- Acronym / sponsor ID
- FWH20060020H
- Conditions
- Photorefractive Keratectomy
- Keywords
- Photorefractive Keratectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Matthew Caldwell
- Study start
- Feb 2006
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 29 May 2006 (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.
The purpose of this study is to compare healing times and subjective pain level responses of nepafenac to placebo after photo refractive keratomileusis (PRK) surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nevanac | Experimental | Drug: nepafenac 0.1%One drop, three times daily, in the assigned eye for the first three postoperative days |
| Acular LS | Placebo comparator | Other: ketorolac 0.4%One drop, three times daily, in the assigned eye for the first three postoperative days |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 19 years or older with healthy ocular status and pre-operative refractive anisometropia of less than 2.000 diopters between eyes undergoing bilateral PRK surgery.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Those desiring PRK in only one eye, those in need of additional topical eye medications, those with history of drug/alcohol abuse, women breastfeeding or pregnant.
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| nepafenac 0.1%Nepafenac 0.1% randomly assigned to one eye, with ketorolac 0.4% in the fellow eye for contralateral post-surgical use. | Drug | Nevanac |
| ketorolac 0.4%Keterolac 0.4% randomly assigned to one eye, with nepafenac 0.1% in the fellow eye for contralateral post-surgical use. | Other | Acular LS |
Primary outcome
Subjective pain
Time frame: Day 5
1 secondary outcome
Rate of epithelial healing
Time frame: Time to event
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 18 Nov 2016.
- Results publication: PubMed 18500088Caldwell M, Reilly C. Effects of topical nepafenac on corneal epithelial healing time and postoperative pain after PRK: a bilateral, prospective, randomized, masked trial. J Refract Surg. 2008 Apr;24(4):377-82. doi: 10.3928/1081597X-20080401-11.
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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.
Matthew Caldwell principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nepafenac 0.1% and ketorolac 0.4% in people with Photorefractive Keratectomy, run by Alcon Research at 1 site in United States.
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 2 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 18 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 United States. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Subjective pain (time frame: Day 5). 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 NCT00330798, 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 18 Nov 2016.