CataractPhase 4NCT00904904
Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery
A Phase 4 study testing Indomethacin ophthalmic solution and Ketorolac Ophthalmic Solution in people with Cataract and Inflammation, run by Bausch & Lomb Incorporated at 1 site in Germany.
Trial summary
This study is being conducted to show that indomethacin is at least as effective as ketorolac for the prevention of ocular inflammation following cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Inflammation
- What is being tested?
- Indomethacin ophthalmic solution and Ketorolac Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2008to Sep 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be planning to undergo cataract surgery on one eye by phacoemulsification with posterior chamber intraocular lens, using topical or general anaesthesia.
- Subjects must have a preoperative flare ≤ 15 ph/ms, measured with a laser flare meter(LFM) without pharmacological pupil dilation, within the 2 months preoperatively.
Who cannot join
- Subjects who have any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents.
- Subjects who take acetylsalicylic acid at doses > 100 mg daily and cannot discontinue usage during the study.
- Subjects who have a history of asthma linked to acetylsalicylic acid or other nonsteroidal anti-inflammatory (NSAI) drug administration.
- Subjects with immunodepression.
- Subjects with a history of intolerance to the study drug or to any NSAI drug.
- Subjects who are monocular for any reason other than cataract.
- Subjects who are treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
This study is being conducted to show that indomethacin is at least as effective as ketorolac for the prevention of ocular inflammation following cataract surgery.
- Conditions
- Cataract, Inflammation
- Being tested
- Indomethacin ophthalmic solution, Ketorolac Ophthalmic Solution
- Medical subject headings
- Cataract, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indomethacin ophthalmic solutionDrug
Indomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery
Ketorolac Ophthalmic SolutionDrug
Ketorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Indomethacin | Experimental | Indomethacin ophthalmic solution 0.1% for post-surgical inflammation Receives: Drug: Indomethacin ophthalmic solution |
| Ketorolac | Active comparator | Ketorolac ophthalmic solution 0.5% for post-surgical inflammation Receives: Drug: Ketorolac Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aqueous flare
Measured: Post-operative day 1 & day 7
Secondary outcomes (2)
Aqueous flare
Measured: Postoperative day 30 and day 90
Change from baseline of retinal thickness
Measured: Postoperative day 30 & day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startApr 2008
- Primary completionJun 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gabriele Brenger, Study director, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00904904
- Sponsor's protocol ID
- 539
- Other IDs
- 2007-004686-18
- Status last verified
- Aug 2012
- First submitted
- 19 May 2009
- Last updated
- 13 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery
- ClinicalTrials.gov ID
- NCT00904904
- Acronym / sponsor ID
- 539
- Conditions
- Cataract, Inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 20 May 2009 (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 is being conducted to show that indomethacin is at least as effective as ketorolac for the prevention of ocular inflammation following cataract surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Indomethacin | Experimental | Drug: Indomethacin ophthalmic solutionIndomethacin ophthalmic solution 0.1% for post-surgical inflammation |
| Ketorolac | Active comparator | Drug: Ketorolac Ophthalmic SolutionKetorolac ophthalmic solution 0.5% for post-surgical inflammation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects must be planning to undergo cataract surgery on one eye by phacoemulsification with posterior chamber intraocular lens, using topical or general anaesthesia.
- Subjects must have a preoperative flare ≤ 15 ph/ms, measured with a laser flare meter(LFM) without pharmacological pupil dilation, within the 2 months preoperatively.
Key exclusion criteria (7 listed)
- Subjects who have any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents.
- Subjects who take acetylsalicylic acid at doses > 100 mg daily and cannot discontinue usage during the study.
- Subjects who have a history of asthma linked to acetylsalicylic acid or other nonsteroidal anti-inflammatory (NSAI) drug administration.
- Subjects with immunodepression.
- Subjects with a history of intolerance to the study drug or to any NSAI drug.
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 |
|---|---|---|
| Indomethacin ophthalmic solutionIndomethacin 0.1% eye drops administered pre-cataract surgery and for 4 weeks post-cataract surgery | Drug | Indomethacin |
| Ketorolac Ophthalmic SolutionKetorolac 0.5% eye drops administered pre-cataract surgery and 4 weeks post-cataract surgery | Drug | Ketorolac |
Primary outcome
Aqueous flare
Time frame: Post-operative day 1 & day 7
2 secondary outcomes
Aqueous flare
Time frame: Postoperative day 30 and day 90
Change from baseline of retinal thickness
Time frame: Postoperative day 30 & day 90
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 13 Aug 2012.
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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.
Gabriele Brenger study director
Bausch & Lomb Incorporated
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 Indomethacin ophthalmic solution and Ketorolac Ophthalmic Solution in people with Cataract and Inflammation, run by Bausch & Lomb Incorporated at 1 site in Germany.
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 7 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 13 Aug 2012. 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 Germany. 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?
Aqueous flare (time frame: Post-operative day 1 & day 7). 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 13 Aug 2012.