CataractsPhase 4NCT01244334
Study of Difluprednate vs. Prednisolone Acetate on Visual Acuity, and Corneal Edema Following Cataract Surgery.
A Phase 4 study testing Difluprednate ophthalmic emulsion 0.05% and Prednisolone acetate 1% in people with Cataracts and Corneal Edema, run by Edward J. Holland at 3 sites in United States.
Trial summary
The purpose of this clinical research study is to investigate the efficacy of predosing patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal thickness. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cataracts, Corneal Edema, Retinal Structural Change, Deposit and Degeneration
- What is being tested?
- Difluprednate ophthalmic emulsion 0.05% and Prednisolone acetate 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2009to Nov 2010
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy male or female 21 years of age or older
- Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-25 days between surgeries.
- Willing and able to administer eye drops and record the times the drops were instilled
- Understand and are willing to sign the Informed Consent form
- Willing to complete the entire course of the study.
Who cannot join
- Use of an eye medication or drops within 48 hours of the scheduled cataract surgery, other than the study medication or procedural solution required for surgery.
- Known sensitivity to any of the ingredients in the study medications or similar medications.
- Scheduled for 2nd eye cataract surgery earlier than 6 days or longer than 25 days apart.
- Corneal edema in either eye.
- Need for regional or general anesthesia during surgery.
- Complicated cataract surgery, including use of iris hooks or iris stretchers.
Show all 21Show fewer
- Sight better than 20/100 in only one eye.
- A history of previous intraocular surgery in either eye.
- A history of uveitis, iritis, or intraocular inflammation.
- Macular pathology of the retina.
- Presence of glaucoma.
- Any confirmed or suspected active viral, bacterial, or fungal keratoconjunctival disease.
- History of steroid-related intraocular pressure (IOP) rise in the study eye.
- Lack of an intact corneal epithelium.
- Pupils that do not dilate to more than 5 mm prior to surgery or you require mechanical stretching of your pupil.
- Diabetes mellitus.
- Required use of a systemic steroidal or non-steroidal anti-inflammatory during the study period.
- Doctor has determined the presence of a condition (i.e., UNCONTROLLED systemic disease) or a situation that may put the subject at significant risk, confound the study results or may interfere significantly with your participation in the study.
- Females, who are pregnant, nursing an infant or planning a pregnancy.
- Currently involved in another investigational study or have participated in one within the 30 days prior to entering this study.
- Unable or unwilling to give signed informed consent prior to participation in any study-related procedures.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cincinnati Eye Institute
Edgewood, Kentucky, 41017
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
Carolina Eyecare
Mt. Pleasant, South Carolina, 29464
About this study
Official title: A Randomized, Masked Multi-center Safety & Efficacy Study of the Effects of Preoperative & Postoperative Cataract Surgery Use of Difluprednate Ophthalmic Emulsion, 0.05% Compared to Prednisolone Acetate Ophthalmic Suspension 1% on Visual Acuity & Corneal Edema.
The purpose of this clinical research study is to investigate the efficacy of predosing patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal thickness.
- Conditions
- Cataracts, Corneal Edema, Retinal Structural Change, Deposit and Degeneration, Visual Acuity Reduced Transiently
- Being tested
- Difluprednate ophthalmic emulsion 0.05%, Prednisolone acetate 1%
- Keywords
- cataract surgery, vision, corneal edema, retinal thickness
- Medical subject headings
- Cataract, Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Difluprednate ophthalmic emulsion 0.05%Drug
Also called Durezol
Difluprednate ophthalmic emulsion 0.05%: 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.
Prednisolone acetate 1%Drug
Also called Prednisolone acetate
Prednisolone acetate 1% : 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.
| Study group | Role | What they receive |
|---|---|---|
| Difluprednate Ophthalmic Emulsion 0.05% | Active comparator | Not described Receives: Drug: Difluprednate ophthalmic emulsion 0.05% |
| Prednisolone acetate suspension 0.1% | Active comparator | Not described Receives: Drug: Prednisolone acetate 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 1
Measured: Change from Baseline in visual acuity, corneal edema, and retinal thickness at Day 1
Secondary outcomes (1)
Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15
Measured: change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2010 (estimated)
- Study startMar 2009
- Primary completionJun 2010
- Study completionNov 2010
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 CataractsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward J. Holland
- Sponsor type
- University, hospital or other
- Collaborators
- Sirion Therapeutics, Inc., Alcon Research, Parsons Medical Communications
- Responsible party
- Sponsor-investigator, Edward J. Holland, Cincinnati Eye Institute Northern Kentucky
- Investigators
- Edward J Holland, MD, Principal investigator, Cincinnati Eye InstituteEric D Donnenfeld, MD, Principal investigator, Ophthalmic Consultants of Long IslandKerry S Solomon, MD, Principal investigator, Carolina Eyecare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01244334
- Sponsor's protocol ID
- SEMC 5/2009-011
- Status last verified
- Aug 2012
- First submitted
- 18 Nov 2010
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Donnenfeld ED, Holland EJ, Solomon KD, Fiore J, Gobbo A, Prince J, Sandoval HP, Shull ER, Perry HD. A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery. Am J Ophthalmol. 2011 Oct;152(4):609-617.e1. doi: 10.1016/j.ajo.2011.03.018. Epub 2011 Jun 25.
PubMed 21704965
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Masked Multi-center Safety & Efficacy Study of the Effects of Preoperative & Postoperative Cataract Surgery Use of Difluprednate Ophthalmic Emulsion, 0.05% Compared to Prednisolone Acetate Ophthalmic Suspension 1% on Visual Acuity & Corneal Edema.
- ClinicalTrials.gov ID
- NCT01244334
- Acronym / sponsor ID
- SEMC 5/2009-011
- Conditions
- Cataracts, Corneal Edema, Retinal Structural Change, Deposit and Degeneration, Visual Acuity Reduced Transiently
- Keywords
- cataract surgery, vision, corneal edema, retinal thickness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Edward J. HollandUniversity, hospital or other
- Collaborators
- Sirion Therapeutics, Inc., Alcon Research, Parsons Medical Communications
- Study start
- Mar 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Nov 2010 (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 clinical research study is to investigate the efficacy of predosing patients undergoing cataract surgery with the potent corticosteroid difluprednate ophthalmic emulsion 0.05% compared to prednisolone acetate 1% on corneal edema (swelling), and retinal thickness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Difluprednate Ophthalmic Emulsion 0.05% | Active comparator | Drug: Difluprednate ophthalmic emulsion 0.05% |
| Prednisolone acetate suspension 0.1% | Active comparator | Drug: Prednisolone acetate 1% |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female 21 years of age or older
- Scheduled to undergo standard cataract surgery with topical anesthesia in both eyes within 6-25 days between surgeries.
- Willing and able to administer eye drops and record the times the drops were instilled
- Understand and are willing to sign the Informed Consent form
- Willing to complete the entire course of the study.
Key exclusion criteria (21 listed)
- Use of an eye medication or drops within 48 hours of the scheduled cataract surgery, other than the study medication or procedural solution required for surgery.
- Known sensitivity to any of the ingredients in the study medications or similar medications.
- Scheduled for 2nd eye cataract surgery earlier than 6 days or longer than 25 days apart.
- Corneal edema in either eye.
- Need for regional or general anesthesia during surgery.
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 |
|---|---|---|
| Difluprednate ophthalmic emulsion 0.05%Also: DurezolDifluprednate ophthalmic emulsion 0.05%: 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop. | Drug | Difluprednate Ophthalmic Emulsion 0.05% |
| Prednisolone acetate 1%Also: Prednisolone acetatePrednisolone acetate 1% : 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop. | Drug | Prednisolone acetate suspension 0.1% |
Primary outcome
Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 1
Time frame: Change from Baseline in visual acuity, corneal edema, and retinal thickness at Day 1
1 secondary outcome
Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15
Time frame: change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 15
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 8 Aug 2012.
- Derived from this study: PubMed 21704965Donnenfeld ED, Holland EJ, Solomon KD, Fiore J, Gobbo A, Prince J, Sandoval HP, Shull ER, Perry HD. A multicenter randomized controlled fellow eye trial of pulse-dosed difluprednate 0.05% versus prednisolone acetate 1% in cataract surgery. Am J Ophthalmol. 2011 Oct;152(4):609-617.e1. doi: 10.1016/j.ajo.2011.03.018. Epub 2011 Jun 25.
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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.
Edward J Holland, MD principal investigator
Cincinnati Eye Institute
Eric D Donnenfeld, MD principal investigator
Ophthalmic Consultants of Long Island
Kerry S Solomon, MD principal investigator
Carolina Eyecare
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Difluprednate ophthalmic emulsion 0.05% and Prednisolone acetate 1% in people with Cataracts and Corneal Edema, run by Edward J. Holland at 3 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 5 inclusion and 21 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 8 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 3 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.
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?
Assess change from Baseline on visual acuity, corneal edema, and retinal thickness at Day 1 (time frame: Change from Baseline in visual acuity, corneal edema, and retinal thickness at Day 1). 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 NCT01244334, 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 8 Aug 2012.