CataractNCT02752646
Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5%
A study testing nepafenac 0.3% and ketorolac in people with Cataract, run by MDbackline, LLC at 2 sites in United States.
Trial summary
This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs ketorolac 0.5% among patients undergoing cataract surgery. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cataract
- What is being tested?
- nepafenac 0.3% and ketorolac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2016to 1 Mar 2017
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years and older currently undergoing femtosecond or manual cataract surgery with or without astigmatic keratotomy.
- Patients willing to take an electronic survey about their tolerability of either study medication.
Who cannot join
- Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings.
- Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit:
- Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgery procedure.
- Clinically significant ocular trauma.
- Active ocular Herpes simplex or Herpes zoster (eye or eyelid) infection.
- Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis)
Show all 14Show fewer
- Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye)
- Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
- Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
- Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
- Ocular surface abnormality that may compromise corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, or map dot fingerprint dystrophy)
- Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to the distribution of the survey
- Participation in this trial in the same patient's fellow eye.
- Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinnati Eye Institute
Edgewood, Kentucky, 41017
Harvard Eye Associates
Laguna Hills, California, 92653
About this study
This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs ketorolac 0.5% among patients undergoing cataract surgery.
Read the detailed description
This will be a randomized, prospective, controlled, open-label study, comparing the tolerability and toxicity of two commercially available non-steroidal anti-inflammatory eye drops, nepafenac 0.3% and ketorolac 0.5% (generic formulation). The study will involve one eye of each subject. The study will follow good clinical practices (GCP). The primary outcome measure will be tolerability of the study medication as measured by the eye drop comfort survey instrument.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nepafenac 0.3%Drug
Also called Ilevro
Patients in this group will receive nepafenac 0.3% eye drops once daily after cataract surgery.
ketorolacDrug
Patients in this group will receive ketorolac 0.5% eye drops four times daily after cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| nepafenac 0.3% | Active comparator | Patients in this arm will receive nepafenac 0.3% eye drops once daily following cataract surgery, combined with a topical antibiotic and steroid. This regimen is FDA approved and withing the standard of care. Receives: Drug: nepafenac 0.3% |
| ketorolac 0.5% | Active comparator | Patients in this arm will receive ketorolac 0.5% eye drops four times daily following cataract surgery, combined with a topical antibiotic and steroid. This regimen is FDA approved and withing the standard of care. Receives: Drug: ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of nepafenac vs ketorolac
Patients will fill out a survey describing eye drop tolerability at 14-28 days
Measured: 14-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study startApr 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CataractStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- MDbackline, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- John A Hovanesian, MD, Principal investigator, UCLA Jules Stein Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752646
- Sponsor's protocol ID
- ALC-15417759
- Status last verified
- Mar 2017
- First submitted
- 25 Apr 2016
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is not a plan to make individual patient data available.
Publications
Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.
PubMed 16196117Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. doi: 10.1097/00003226-200310000-00008.
PubMed 14508260
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Toxicity of Topically Applied Nepafenac 0.3% vs Ketorolac 0.5%
- ClinicalTrials.gov ID
- NCT02752646
- Acronym / sponsor ID
- ALC-15417759
- Conditions
- Cataract
- Keywords
- cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- MDbackline, LLCUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Apr 2016
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 27 Apr 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.
This study will examine the tolerability and toxicity of topically applied Nepafenac 0.3% vs ketorolac 0.5% among patients undergoing cataract surgery.
Detailed description
This will be a randomized, prospective, controlled, open-label study, comparing the tolerability and toxicity of two commercially available non-steroidal anti-inflammatory eye drops, nepafenac 0.3% and ketorolac 0.5% (generic formulation). The study will involve one eye of each subject. The study will follow good clinical practices (GCP). The primary outcome measure will be tolerability of the study medication as measured by the eye drop comfort survey instrument.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nepafenac 0.3% | Active comparator | Drug: nepafenac 0.3%Patients in this arm will receive nepafenac 0.3% eye drops once daily following cataract surgery, combined with a topical antibiotic and steroid. This regimen is FDA approved and withing the standard of care. |
| ketorolac 0.5% | Active comparator | Drug: ketorolacPatients in this arm will receive ketorolac 0.5% eye drops four times daily following cataract surgery, combined with a topical antibiotic and steroid. This regimen is FDA approved and withing the standard of care. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years and older currently undergoing femtosecond or manual cataract surgery with or without astigmatic keratotomy.
- Patients willing to take an electronic survey about their tolerability of either study medication.
Key exclusion criteria (14 listed)
- Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings.
- Any of the following ocular (eye or eyelid) conditions in either eye within 1 Months prior to the enrollment visit:
- Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis
- Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
- Eyelid abnormalities that significantly affect lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis)
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 0.3%Also: IlevroPatients in this group will receive nepafenac 0.3% eye drops once daily after cataract surgery. | Drug | nepafenac 0.3% |
| ketorolacPatients in this group will receive ketorolac 0.5% eye drops four times daily after cataract surgery. | Drug | ketorolac 0.5% |
Primary outcome
Tolerability of nepafenac vs ketorolac
Time frame: 14-28 days
Patients will fill out a survey describing eye drop tolerability at 14-28 days
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 7 Mar 2017.
- Results publication: PubMed 16196117Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.
- Results publication: PubMed 14508260Bron AJ, Evans VE, Smith JA. Grading of corneal and conjunctival staining in the context of other dry eye tests. Cornea. 2003 Oct;22(7):640-50. doi: 10.1097/00003226-200310000-00008.
- Individual participant dataSharing planned: No. There is not a plan to make individual patient data available.
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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.
John A Hovanesian, MD principal investigator
UCLA Jules Stein Eye Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nepafenac 0.3% and ketorolac in people with Cataract, run by MDbackline, LLC at 2 sites 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 14 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 7 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
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?
Tolerability of nepafenac vs ketorolac (time frame: 14-28 days). 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 NCT02752646, which also lists 2 linked publications.
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 7 Mar 2017.