Intraocular PressurePhase 4NCT01995890
Effect of Nepafenac Eye Drops on Intraocular Pressure in Normal Eyes
A Phase 4 study testing nepafenac in people with Intraocular Pressure, run by Dr T V Patel Eye Institute at 1 site in India.
Trial summary
The Nevanac product information insert says that it can cause increase in eye pressure in 5-10% of patients. There is very little published literature on the effect of topical Nepafenac eye drops on eye pressure in normal people. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- What is being tested?
- nepafenac
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 327 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2012to Apr 2013
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Best corrected visual acuity better than 20/80 in both eyes
- Intraocular pressure ≤21 mmHg in both eyes
- Open angles on 4 mirror gonioscopy without indentation
- Normal optic disc on stereoscopic examination and photographs
Who cannot join
- Change in the systemic medication profile during the course of the study
- Allergy to nepafenac molecule
- Corneal thinning/corneal infections
- Any intraocular surgery in past 3 months
- Pregnancy or those planning to conceive
- Breast feeding patients
- Unwillingness to participate in the trial
- Concomitant use of any other ocular drug (except artificial tears)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Nepafenac Eye Drops on Intraocular Pressure - a Randomized Prospective Study
The Nevanac product information insert says that it can cause increase in eye pressure in 5-10% of patients. There is very little published literature on the effect of topical Nepafenac eye drops on eye pressure in normal people. The purpose of our study is to report this effect with a working hypothesis that there is no increase in eye pressure following use of Nepafenac eye drops.
- Conditions
- Intraocular Pressure
- Being tested
- nepafenac
- Keywords
- nepafenac eye drops, intraocular pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nepafenacDrug
Also called Nevanac
| Study group | Role | What they receive |
|---|---|---|
| nepafenac | Experimental | Nepafenac 0.1% eye drops, 3 times a day Receives: Drug: nepafenac |
| control | No intervention | No intervention in the control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Intraocular pressure elevation of more than 4 mmHg from baseline
Measured: 4 weeks
Intraocular pressure
Intraocular pressure elevation of more than 4 mmHg from baseline
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startDec 2012
- Primary completionFeb 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intraocular PressureStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr T V Patel Eye Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paaraj R Dave, MD, Principal investigator, TV Patel Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01995890
- Sponsor's protocol ID
- TVPEI
- Status last verified
- Nov 2013
- First submitted
- 22 Nov 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gamache DA, Graff G, Brady MT, Spellman JM, Yanni JM. Nepafenac, a unique nonsteroidal prodrug with potential utility in the treatment of trauma-induced ocular inflammation: I. Assessment of anti-inflammatory efficacy. Inflammation. 2000 Aug;24(4):357-70. doi: 10.1023/a:1007049015148.
PubMed 10850857Chiba T, Kashiwagi K, Chiba N, Tsukahara S. Effect of non-steroidal anti-inflammatory ophthalmic solution on intraocular pressure reduction by latanoprost in patients with primary open angle glaucoma or ocular hypertension. Br J Ophthalmol. 2006 Mar;90(3):314-7. doi: 10.1136/bjo.2005.080895.
PubMed 16488953Warren KA, Fox JE. Topical nepafenac as an alternate treatment for cystoid macular edema in steroid responsive patients. Retina. 2008 Nov-Dec;28(10):1427-34. doi: 10.1097/IAE.0b013e31817e7ead.
PubMed 18664937
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nepafenac Eye Drops on Intraocular Pressure - a Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT01995890
- Acronym / sponsor ID
- TVPEI
- Conditions
- Intraocular Pressure
- Keywords
- nepafenac eye drops, intraocular pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Dr T V Patel Eye InstituteUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 27 Nov 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.
The Nevanac product information insert says that it can cause increase in eye pressure in 5-10% of patients. There is very little published literature on the effect of topical Nepafenac eye drops on eye pressure in normal people. The purpose of our study is to report this effect with a working hypothesis that there is no increase in eye pressure following use of Nepafenac eye drops.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nepafenac | Experimental | Drug: nepafenacNepafenac 0.1% eye drops, 3 times a day |
| control | No intervention | –No intervention in the control arm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Best corrected visual acuity better than 20/80 in both eyes
- Intraocular pressure ≤21 mmHg in both eyes
- Open angles on 4 mirror gonioscopy without indentation
- Normal optic disc on stereoscopic examination and photographs
Key exclusion criteria (8 listed)
- Change in the systemic medication profile during the course of the study
- Allergy to nepafenac molecule
- Corneal thinning/corneal infections
- Any intraocular surgery in past 3 months
- Pregnancy or those planning to conceive
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 |
|---|---|---|
| nepafenacAlso: Nevanac | Drug | nepafenac |
Primary outcome
Intraocular pressure
Time frame: 4 weeks
Intraocular pressure elevation of more than 4 mmHg from baseline
Intraocular pressure
Time frame: 8 weeks
Intraocular pressure elevation of more than 4 mmHg from baseline
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 27 Nov 2013.
- Background: PubMed 10850857Gamache DA, Graff G, Brady MT, Spellman JM, Yanni JM. Nepafenac, a unique nonsteroidal prodrug with potential utility in the treatment of trauma-induced ocular inflammation: I. Assessment of anti-inflammatory efficacy. Inflammation. 2000 Aug;24(4):357-70. doi: 10.1023/a:1007049015148.
- Results publication: PubMed 16488953Chiba T, Kashiwagi K, Chiba N, Tsukahara S. Effect of non-steroidal anti-inflammatory ophthalmic solution on intraocular pressure reduction by latanoprost in patients with primary open angle glaucoma or ocular hypertension. Br J Ophthalmol. 2006 Mar;90(3):314-7. doi: 10.1136/bjo.2005.080895.
- Results publication: PubMed 18664937Warren KA, Fox JE. Topical nepafenac as an alternate treatment for cystoid macular edema in steroid responsive patients. Retina. 2008 Nov-Dec;28(10):1427-34. doi: 10.1097/IAE.0b013e31817e7ead.
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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.
Paaraj R Dave, MD principal investigator
TV Patel Eye Institute
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 in people with Intraocular Pressure, run by Dr T V Patel Eye Institute at 1 site in India.
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 27 Nov 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 India. 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 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?
Intraocular pressure (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT01995890, which also lists 3 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 27 Nov 2013.