TrichiasisNCT01949454
Fluorometholone as Ancillary Therapy for TT Surgery
A study testing Fluorometholone 0.1% ophthalmic solution in people with Trichiasis and Trachoma, run by University of Pennsylvania at 1 site in Ethiopia.
Trial summary
The investigators aim to evaluate a new potentially cost-effective approach to improving trichiasis surgery outcomes, perioperative topical anti-inflammatory therapy. The investigators hypothesize that adjunctive topical fluorometholone therapy following trichiasis surgery will reduce the risk of recurrent trichiasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trichiasis, Trachoma, Bilamellar Tarsal Rotation
- What is being tested?
- Fluorometholone 0.1% ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteEthiopia
- Study dates
- Nov 2013to Apr 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or more
- Diagnosis with trachomatous trichiasis
- Plan for lid rotation surgery (Bilamellar Tarsal Rotation) on at least one upper eyelid
- LOCS 3 cataract grading is level 3 or less for the nuclear cataract scale, and level 2 or less for the cortical cataract and posterior subcapsular cataract scales.
- Intraocular pressure between 8-20 mm Hg in the study eye.
Who cannot join
- Contraindications to the use of the test articles
- Known allergy or sensitivity to any medication used in this study, including the study medication or its components (e.g., fluorometholone)
- Currently taking more than two ocular anti-hypertensive medications in the study eye (prior IOP-lowering surgery is acceptable; combinations of two agents such as Cosopt and Combigan are considered two medications)
- Glaucoma sufficiently advanced that an intraocular pressure spike potentially would put the patient at substantial risk of vision loss, per study ophthalmologist's judgment.
- Non-phakic (i.e., pseudophakic or aphakic) study eye (contralateral non-phakic eye is permitted).
- Other than trachoma, any active ocular infections (bacterial, viral, or fungal), or any active ocular inflammation (e.g., scleritis, iritis).
Show all 14Show fewer
- History or diagnosis of ocular herpes or presence of a corneal lesion of suspected herpetic origin; or a diagnosis or suspected diagnosis of ophthalmic mycobacterial infection in either eye.
- Corneal or scleral thinning in either eye.
- A severe / serious ocular pathology or medical condition which may preclude study completion.
- Any condition for which it is anticipated ocular or systemic corticosteroid therapy would be required.
- Unwilling to discontinue use of contact lenses for the duration of the study (should the unusual circumstance of a trachomatous trichiasis patient who uses contact lenses be encountered)
- Any significant illness or condition that could, in the investigator's or sub-investigator's opinion, be expected to interfere with the study parameters or study conduct; or put the subject at significant risk
- For women of childbearing age, currently pregnant and/or breastfeeding, as obtained by self-report (because of concerns about the (programmatic) use of azithromycin in this setting).
- Cataract in the study eye, defined as LOCS-3 cataract grading is level 3.1 or more for the nuclear cataract scale, or level 2.1 or more for the cortical cataract or posterior subcapsular cataract scales.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluorometholone 0.1% as Perioperative Adjunct Therapy for Lid-rotation Surgery in Trachomatous Entropion and Trichiasis, Dose-varying Study
The investigators aim to evaluate a new potentially cost-effective approach to improving trichiasis surgery outcomes, perioperative topical anti-inflammatory therapy. The investigators hypothesize that adjunctive topical fluorometholone therapy following trichiasis surgery will reduce the risk of recurrent trichiasis. The rationale for this hypothesis is that interruption of inflammation postoperatively would reduce postoperative scarring, leading to better outcomes. As an initial step toward evaluating this modality, the investigators believe it to be necessary to evaluate topical corticosteroid therapy in a safety-oriented study, for which the investigators also hypothesize that fluorometholone will have a perioperative safety profile acceptable for large-scale programmatic use. Topical corticosteroid therapy is associated with potential risks of cataract induction and intraocular pressure (IOP) elevation in susceptible individuals. Fluorometholone has lower intraocular penetration than alternative corticosteroids, with correspondingly less IOP-raising effect while still having favorable effects on conjunctival inflammation, and is a low-cost generic drug. Its poor delivery of corticosteroid into the eye itself provides an advantage in this setting, as the major side effects of therapy are the result of intraocular effects, and therapy only is needed to the conjunctiva. However, prior to use in a large-scale trial it is sensible to make sure adverse outcomes are not observed in a substantial number of TT patients in a smaller scale trial. Secondary goals of such a trial are to evaluate alternative topical corticosteroid dosing schedules to identify an optimal dosing schedule and to identify any preliminary signals of potential efficacy.
Read the detailed description
Protocol Title: Fluorometholone 0.1% as Perioperative Adjunct Therapy for Lid-rotation Surgery in Trachomatous Entropion and Trichiasis, Dose-varying Study
Study Design: Randomized, double-masked, dose-ranging study of three dose levels of fluorometholone 0.1% or placebo in one eye of subjects with trachomatous trichiasis (TT) undergoing lid rotation surgery
Primary Study Objective: Evaluate the safety and tolerability of three (3) doses of fluorometholone 0.1% in subjects with trachomatous trichiasis (TT) undergoing lid rotation surgery (Bilamellar Tarsal Rotation)
Secondary Study Objective: Conduct a preliminary assessment of the efficacy of three (3) doses of fluorometholone 0.1% in subjects with trachomatous trichiasis (TT) undergoing lid rotation surgery (Bilamellar Tarsal Rotation)
Number of Subjects: Up to 156 eyes of up to 156 subjects
Study Population: Subjects with trachomatous trichiasis (TT) undergoing lid rotation surgery (Bilamellar Tarsal Rotation)
Test Articles:
- Fluorometholone 0.1% one drop twice daily for four weeks
- Placebo one drop twice daily for four weeks
- Fluorometholone 0.1% one drop four times daily for four weeks
- Placebo one drop four times daily for four weeks
- Fluorometholone 0.1% one drop four times daily for eight weeks
- Placebo one drop four times daily for eight weeks
Visit Schedule: Following trichiasis surgery on Day 0, subjects will return for study visits approximately on Days 14, 28, 56, 90, and 365
Tolerability Parameters:
- Treatment-emergent ocular symptoms/signs
- Discontinuation of drug / treatment because of side effects
Safety Parameters:
- Intraocular pressure elevation ≥30 mm Hg
- Cataract
- Adverse events
- Treatment emergent abnormal ophthalmic findings
- Treatment emergent external examination findings
- Visual acuity
Efficacy Parameters:
- Trichiasis recurrence
- Entropion recurrence
- Trachoma activity grade (to the extent activity can be graded in eyes with severe trachomatous scarring)
- Conditions
- Trichiasis, Trachoma, Bilamellar Tarsal Rotation
- Being tested
- Fluorometholone 0.1% ophthalmic solution, Artificial tears (Placebo)
- Keywords
- trachoma, trichiasis, trachomatous trichiasis, bilamellar tarsal rotation, fluorometholone, placebo controlled
- Medical subject headings
- Trichiasis, Trachoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorometholone 0.1% ophthalmic solutionDrug
Artificial tears (Placebo)Other
Artificial tears (Placebo)
| Study group | Role | What they receive |
|---|---|---|
| Fluorometholone 0.1% 1 gtt bid x4weeks | Experimental | Fluorometholone 0.1% 1 drop two times daily for four weeks Receives: Drug: Fluorometholone 0.1% ophthalmic solution |
| Artificial Tears 1 gtt bid x4 weeks | Placebo comparator | Not described Receives: Other: Artificial tears (Placebo) |
| Fluorometholone 0.1% 1 gtt qid x 4 weeks | Experimental | Fluorometholone 0.1% 1 drop four times daily for four weeks Receives: Drug: Fluorometholone 0.1% ophthalmic solution |
| Artificial Tears 1 gtt qid x4 weeks | Placebo comparator | Not described Receives: Other: Artificial tears (Placebo) |
| Fluorometholone 0.1% 1 gtt qid x 8 weeks | Experimental | Fluorometholone 0.1% 1 drop four times daily for eight weeks Receives: Drug: Fluorometholone 0.1% ophthalmic solution |
| Artificial Tears 1 gtt qid x8 weeks | Placebo comparator | Not described Receives: Other: Artificial tears (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments
Incident cataract is defined as either: 1) a two-step worsening on the nuclear, cortical, and/or posterior subcapsular LOCS-3 scale; or 2) undergoing cataract surgery prior to that point in follow-up.
Intraocular pressure elevation
Other dose-limiting toxicity: 1) SAEs (see below) judged as likely related to the treatment by the investigators; 2) vision-threatening non-trachoma infections, e.g., corneal ulcer; 3) anaphylaxis or other events requiring immediate resuscitation; or 4) when the clinician-investigators determine that other AEs observed in a subject would make future applications of the treatment contraindicated on the basis of side effects.
Measured: Within one year of randomization
Secondary outcomes (1)
Recurrence of trichiasis in the study eye
Lashes touching the globe or cornea
Measured: Within one year of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrichiasisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Lions Club International Foundation, Berhan Public Health and Eye Care Consultancy PLC, Grarbet Tehadiso Mahber
- Responsible party
- Principal investigator, John Kempen, University of Pennsylvania
- Investigators
- John H Kempen, MD MPH PhD, Principal investigator, University of PennsylvaniaWondu Alemayehu, MD, MPH, Principal investigator, Berhan Public Health & Eye Care Consultancy PLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949454
- Sponsor's protocol ID
- SF1707/UND
- Status last verified
- Apr 2016
- First submitted
- 19 Sep 2013
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorometholone 0.1% as Perioperative Adjunct Therapy for Lid-rotation Surgery in Trachomatous Entropion and Trichiasis, Dose-varying Study
- ClinicalTrials.gov ID
- NCT01949454
- Acronym / sponsor ID
- SF1707/UND
- Conditions
- Trichiasis, Trachoma, Bilamellar Tarsal Rotation
- Keywords
- trachoma, trichiasis, trachomatous trichiasis, bilamellar tarsal rotation, fluorometholone, placebo controlled
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Lions Club International Foundation, Berhan Public Health and Eye Care Consultancy PLC, Grarbet Tehadiso Mahber
- Study start
- Nov 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 24 Sep 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 investigators aim to evaluate a new potentially cost-effective approach to improving trichiasis surgery outcomes, perioperative topical anti-inflammatory therapy. The investigators hypothesize that adjunctive topical fluorometholone therapy following trichiasis surgery will reduce the risk of recurrent trichiasis. The rationale for this hypothesis is that interruption of inflammation postoperatively would reduce postoperative scarring, leading to better outcomes. As an initial step toward evaluating this modality, the investigators believe it to be necessary to evaluate topical corticosteroid therapy in a safety-oriented study, for which the investigators also hypothesize that fluorometholone will have a perioperative safety profile acceptable for large-scale programmatic use. Topical corticosteroid therapy is associated with potential risks of cataract induction and intraocular pressure (IOP) elevation in susceptible individuals. Fluorometholone has lower intraocular penetration than alternative corticosteroids, with correspondingly less IOP-raising effect while still having favorable effects on conjunctival inflammation, and is a low-cost generic drug. Its poor delivery of corticosteroid into the eye itself provides an advantage in this setting, as the major side effects of therapy are the result of intraocular effects, and therapy only is needed to the conjunctiva. However, prior to use in a large-scale trial it is sensible to make sure adverse outcomes are not observed in a substantial number of TT patients in a smaller scale trial. Secondary goals of such a trial are to evaluate alternative topical corticosteroid dosing schedules to identify an optimal dosing schedule and to identify any preliminary signals of potential efficacy.
Detailed description
Protocol Title: Fluorometholone 0.1% as Perioperative Adjunct Therapy for Lid-rotation Surgery in Trachomatous Entropion and Trichiasis, Dose-varying Study
Study Design: Randomized, double-masked, dose-ranging study of three dose levels of fluorometholone 0.1% or placebo in one eye of subjects with trachomatous trichiasis (TT) undergoing lid rotation surgery
Primary Study Objective: Evaluate the safety and tolerability of three (3) doses of fluorometholone 0.1% in subjects with trachomatous trichiasis (TT) undergoing lid rotation surgery (Bilamellar Tarsal Rotation)
Secondary Study Objective: Conduct a preliminary assessment of the efficacy of three (3) doses of fluorometholone 0.1% in subjects with trachomatous trichiasis (TT) undergoing lid rotation surgery (Bilamellar Tarsal Rotation)
Number of Subjects: Up to 156 eyes of up to 156 subjects
Study Population: Subjects with trachomatous trichiasis (TT) undergoing lid rotation surgery (Bilamellar Tarsal Rotation)
Test Articles:
- Fluorometholone 0.1% one drop twice daily for four weeks
- Placebo one drop twice daily for four weeks
- Fluorometholone 0.1% one drop four times daily for four weeks
- Placebo one drop four times daily for four weeks
- Fluorometholone 0.1% one drop four times daily for eight weeks
- Placebo one drop four times daily for eight weeks
Visit Schedule: Following trichiasis surgery on Day 0, subjects will return for study visits approximately on Days 14, 28, 56, 90, and 365
Tolerability Parameters:
- Treatment-emergent ocular symptoms/signs
- Discontinuation of drug / treatment because of side effects
Safety Parameters:
- Intraocular pressure elevation ≥30 mm Hg
- Cataract
- Adverse events
- Treatment emergent abnormal ophthalmic findings
- Treatment emergent external examination findings
- Visual acuity
Efficacy Parameters:
- Trichiasis recurrence
- Entropion recurrence
- Trachoma activity grade (to the extent activity can be graded in eyes with severe trachomatous scarring)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Fluorometholone 0.1% 1 gtt bid x4weeks | Experimental | Drug: Fluorometholone 0.1% ophthalmic solutionFluorometholone 0.1% 1 drop two times daily for four weeks |
| Artificial Tears 1 gtt bid x4 weeks | Placebo comparator | Other: Artificial tears (Placebo) |
| Fluorometholone 0.1% 1 gtt qid x 4 weeks | Experimental | Drug: Fluorometholone 0.1% ophthalmic solutionFluorometholone 0.1% 1 drop four times daily for four weeks |
| Artificial Tears 1 gtt qid x4 weeks | Placebo comparator | Other: Artificial tears (Placebo) |
| Fluorometholone 0.1% 1 gtt qid x 8 weeks | Experimental | Drug: Fluorometholone 0.1% ophthalmic solutionFluorometholone 0.1% 1 drop four times daily for eight weeks |
| Artificial Tears 1 gtt qid x8 weeks | Placebo comparator | Other: Artificial tears (Placebo) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or more
- Diagnosis with trachomatous trichiasis
- Plan for lid rotation surgery (Bilamellar Tarsal Rotation) on at least one upper eyelid
- LOCS 3 cataract grading is level 3 or less for the nuclear cataract scale, and level 2 or less for the cortical cataract and posterior subcapsular cataract scales.
- Intraocular pressure between 8-20 mm Hg in the study eye.
Key exclusion criteria (14 listed)
- Contraindications to the use of the test articles
- Known allergy or sensitivity to any medication used in this study, including the study medication or its components (e.g., fluorometholone)
- Currently taking more than two ocular anti-hypertensive medications in the study eye (prior IOP-lowering surgery is acceptable; combinations of two agents such as Cosopt and Combigan are considered two medications)
- Glaucoma sufficiently advanced that an intraocular pressure spike potentially would put the patient at substantial risk of vision loss, per study ophthalmologist's judgment.
- Non-phakic (i.e., pseudophakic or aphakic) study eye (contralateral non-phakic eye is permitted).
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 |
|---|---|---|
| Fluorometholone 0.1% ophthalmic solution | Drug | Fluorometholone 0.1% 1 gtt bid x4weeks, Fluorometholone 0.1% 1 gtt qid x 4 weeks, Fluorometholone 0.1% 1 gtt qid x 8 weeks |
| Artificial tears (Placebo)Artificial tears (Placebo) | Other | Artificial Tears 1 gtt bid x4 weeks, Artificial Tears 1 gtt qid x4 weeks, Artificial Tears 1 gtt qid x8 weeks |
Primary outcome
Safety assessments
Time frame: Within one year of randomization
Incident cataract is defined as either: 1) a two-step worsening on the nuclear, cortical, and/or posterior subcapsular LOCS-3 scale; or 2) undergoing cataract surgery prior to that point in follow-up. Intraocular pressure elevation Other dose-limiting toxicity: 1) SAEs (see below) judged as likely related to the treatment by the investigators; 2) vision-threatening non-trachoma infections, e.g., corneal ulcer; 3) anaphylaxis or other events requiring immediate resuscitation; or 4) when the clinician-investigators determine that other AEs observed in a subject would make future applications of the treatment contraindicated on the basis of side effects.
1 secondary outcome
Recurrence of trichiasis in the study eye
Time frame: Within one year of randomization
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 21 Apr 2016.
Related trials for Trichiasis
Recruiting
RESTORE: Comparing Two Approaches to Repeat TT Surgery Performed by Integrated Eye Care Workers (IECWs)
Trachoma, Eye Diseases
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 H Kempen, MD MPH PhD principal investigator
University of Pennsylvania
Wondu Alemayehu, MD, MPH principal investigator
Berhan Public Health & Eye Care Consultancy PLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorometholone 0.1% ophthalmic solution in people with Trichiasis and Trachoma, run by University of Pennsylvania at 1 site in Ethiopia.
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 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 21 Apr 2016. 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 Ethiopia. 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. Some participants in this study may receive a placebo. 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?
Safety assessments (time frame: Within one year of randomization). 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 21 Apr 2016.