Post-operative Healing Following Blepharoplasty and Ptosis RepairNCT01749241
Efficacy of Loteprednol Ointment Following Eyelid Surgery
A study testing Loteprednol etabonate ophthalmic ointment in people with Post-operative Healing Following Blepharoplasty and Ptosis Repair, run by University of California, San Diego at 1 site in United States.
Trial summary
Inflammation occurs after any type of incisional surgery. This study will evaluate the efficacy of Loteprednol etabonate ointment vs. Soothe ointment (vehicle) for postoperative inflammation after routine eyelid surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-operative Healing Following Blepharoplasty and Ptosis Repair
- What is being tested?
- Loteprednol etabonate ophthalmic ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to May 2015
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Scheduled for bilateral eyelid surgery
- Willing and able to return for all study visits
- Willing and able to administer treatments as required
- Understand and sign informed consent approved by UCSD institutional review board
Who cannot join
- History of allergy to investigational drug (Loteprednol etabonate) or ingredient in drug including petrolatum
- History of collagen vascular disease and receiving concurrent treatment that could interfere with interpretation of study results
- Concurrent ocular therapy with nonsteroidal anti-inflammatory drugs, mast cell stabilizers, antihistamines, decongestants, immunosuppresants, and systemic or ocular corticosteroids
- History of immunodeficiency
- Prior eyelid or facial surgery
- Prior ocular or orbital trauma
Show all 10Show fewer
- History of ocular hypertension, steroid responder, or glaucoma
- Pregnancy or lactation
- Uncontrolled systemic disease or significant illness
- Any other condition the investigator believe would pose a significant hazard to the subject if the investigational therapy were initiated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Loteprednol Etabonate Ophthalmic Ointment vs. Soothe Night Time Ointment for Inflammation Following Eyelid Surgery
Inflammation occurs after any type of incisional surgery. This study will evaluate the efficacy of Loteprednol etabonate ointment vs. Soothe ointment (vehicle) for postoperative inflammation after routine eyelid surgery.
Read the detailed description
Eyelid surgery such as blepharoplasty is often performed for functional and cosmetic indications. Following any incisional surgery, postoperative inflammation occurs at the surgical site. This study will evaluate the efficacy of reducing postoperative inflammation after bilateral eyelid surgery using Loteprednol etabonate (steroid) vs. Soothe ointment (vehicle of Loteprednol etabonate). Common postoperative changes at the incision include: erythema, thickening/elevation of the skin, pigmentary changes and pain. The use of a topically applied steroid would be expected to reduce inflammation and this study will evaluate this. For each patient, one eyelid will be randomly chosen to treat with medication and the other eyelid will be treated with vehicle ointment and by using the same patient, each patient will be internally controlled. Antibiotic prophylaxis is often given after eyelid surgery and this will be used in all patients in the study.
- Being tested
- Loteprednol etabonate ophthalmic ointment, Vehicle Ophthalmic Ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loteprednol etabonate ophthalmic ointmentDrug
Also called Lotemax ophthalmic ointment
Thin ribbon ointment to assigned eye twice daily for 14 days
Vehicle Ophthalmic OintmentDrug
Thin ribbon ointment to assigned eye twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Loteprednol etabonate ointment | Experimental | This is the arm which contains loteprednol steroid Receives: Drug: Loteprednol etabonate ophthalmic ointment |
| Vehicle Ointment | Other | This arm contains vehicle only. Receives: Drug: Vehicle Ophthalmic Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation
Inflammatory changes of the periocular skin will be assessed by several criteria including: 1. Erythema 2. Wound elevation 3. Pigmentary changes 4. Exudate 5. Excoriation 6. Crusting 7. Scaling 8. Pain 9. Itching
Measured: 24 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: no participant enrolled
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 Post-operative Healing Following Blepharoplasty and Ptosis RepairStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Shiley Eye Center, Bausch & Lomb Incorporated
- Responsible party
- Principal investigator, Bobby Korn, MD, PhD, University of California, San Diego
- Investigators
- Bobby Korn, MD PhD, Principal investigator, UCSD Med
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749241
- Sponsor's protocol ID
- BL31929
- Status last verified
- Jul 2019
- First submitted
- 10 Dec 2012
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Comstock TL, Paterno MR, Singh A, Erb T, Davis E. Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery. Clin Ophthalmol. 2011;5:177-86. doi: 10.2147/OPTH.S16832. Epub 2011 Feb 10.
PubMed 21383946A double-masked, placebo-controlled evaluation of 0.5% loteprednol etabonate in the treatment of postoperative inflammation. The Loteprednol Etabonate Postoperative Inflammation Study Group 2. Ophthalmology. 1998 Sep;105(9):1780-6. doi: 10.1016/s0161-6420(98)99054-6.
PubMed 9754192
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loteprednol Etabonate Ophthalmic Ointment vs. Soothe Night Time Ointment for Inflammation Following Eyelid Surgery
- ClinicalTrials.gov ID
- NCT01749241
- Acronym / sponsor ID
- BL31929
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participant enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Shiley Eye Center, Bausch & Lomb Incorporated
- Study start
- Sep 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 13 Dec 2012 (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.
Inflammation occurs after any type of incisional surgery. This study will evaluate the efficacy of Loteprednol etabonate ointment vs. Soothe ointment (vehicle) for postoperative inflammation after routine eyelid surgery.
Detailed description
Eyelid surgery such as blepharoplasty is often performed for functional and cosmetic indications. Following any incisional surgery, postoperative inflammation occurs at the surgical site. This study will evaluate the efficacy of reducing postoperative inflammation after bilateral eyelid surgery using Loteprednol etabonate (steroid) vs. Soothe ointment (vehicle of Loteprednol etabonate). Common postoperative changes at the incision include: erythema, thickening/elevation of the skin, pigmentary changes and pain. The use of a topically applied steroid would be expected to reduce inflammation and this study will evaluate this. For each patient, one eyelid will be randomly chosen to treat with medication and the other eyelid will be treated with vehicle ointment and by using the same patient, each patient will be internally controlled. Antibiotic prophylaxis is often given after eyelid surgery and this will be used in all patients in the study.
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 |
|---|---|---|
| Loteprednol etabonate ointment | Experimental | Drug: Loteprednol etabonate ophthalmic ointmentThis is the arm which contains loteprednol steroid |
| Vehicle Ointment | Other | Drug: Vehicle Ophthalmic OintmentThis arm contains vehicle only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years old
- Scheduled for bilateral eyelid surgery
- Willing and able to return for all study visits
- Willing and able to administer treatments as required
- Understand and sign informed consent approved by UCSD institutional review board
Key exclusion criteria (10 listed)
- History of allergy to investigational drug (Loteprednol etabonate) or ingredient in drug including petrolatum
- History of collagen vascular disease and receiving concurrent treatment that could interfere with interpretation of study results
- Concurrent ocular therapy with nonsteroidal anti-inflammatory drugs, mast cell stabilizers, antihistamines, decongestants, immunosuppresants, and systemic or ocular corticosteroids
- History of immunodeficiency
- Prior eyelid or facial 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 |
|---|---|---|
| Loteprednol etabonate ophthalmic ointmentAlso: Lotemax ophthalmic ointmentThin ribbon ointment to assigned eye twice daily for 14 days | Drug | Loteprednol etabonate ointment |
| Vehicle Ophthalmic OintmentThin ribbon ointment to assigned eye twice daily for 14 days | Drug | Vehicle Ointment |
Primary outcome
Inflammation
Time frame: 24 weeks after surgery
Inflammatory changes of the periocular skin will be assessed by several criteria including: 1. Erythema 2. Wound elevation 3. Pigmentary changes 4. Exudate 5. Excoriation 6. Crusting 7. Scaling 8. Pain 9. Itching
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Results publication: PubMed 21383946Comstock TL, Paterno MR, Singh A, Erb T, Davis E. Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery. Clin Ophthalmol. 2011;5:177-86. doi: 10.2147/OPTH.S16832. Epub 2011 Feb 10.
- Results publication: PubMed 9754192A double-masked, placebo-controlled evaluation of 0.5% loteprednol etabonate in the treatment of postoperative inflammation. The Loteprednol Etabonate Postoperative Inflammation Study Group 2. Ophthalmology. 1998 Sep;105(9):1780-6. doi: 10.1016/s0161-6420(98)99054-6.
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.
Bobby Korn, MD PhD principal investigator
UCSD Med
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loteprednol etabonate ophthalmic ointment in people with Post-operative Healing Following Blepharoplasty and Ptosis Repair, run by University of California, San Diego 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 5 inclusion and 10 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: withdrawn, as of the sponsor's last update on 2 Aug 2019. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Inflammation (time frame: 24 weeks after surgery). 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 NCT01749241, 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 2 Aug 2019.