Dry Eye DiseasePhase 4NCT00407043
Multicenter, Randomized, Controlled Study of the Effect of Lotemax on Initiation of Dry Eye Treatment With Restasis
A Phase 4 study testing Lotemax and Restasis in people with Dry Eye Disease and Keratoconjunctivitis Sicca, run by Ophthalmic Consultants of Long Island at 1 site in United States.
Trial summary
To evaluate the impact of Lotemax on the initiation of Restasis therapy in patients with dry eye. It is hypothesized that the anti-inflammatory activity of Lotemax may help mitigate the stinging with cyclosporine administration and the dry eye signs and symptoms experienced during the initiation of therapy. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Disease, Keratoconjunctivitis Sicca
- What is being tested?
- Lotemax and Restasis
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Sep 2007
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 30 and 80 inclusive.
- Has not worn contact lenses for at least 1 month prior to the study and agrees to not wear contact lenses during study.
- Oral medications stable 1 month prior to study.
- Oral medications anticipated to be stable during 60 day study.
- Patient is in generally good \& stable overall health.
- Patient likely to comply with eye drop regimen, study guidelines \& study visits.
- Corneal stain > 1+ or Conjunctival stain > 1+ or OSDI equal or > 5 or using regular artificial tears at least on average twice daily.
- Informed consent signed.
Who cannot join
- History of Stevens-Johnson Syndrome or Ocular Pemphigoid.
- Punctal plugs inserted or punctal cautery in the past 3 months.
- Intra-ocular surgery within 6 months or ocular laser surgery within 3 months.
- History of liver disease.
- Pregnant or lactating women.
- Severe clinical vitamin deficiencies or history of vitamin overdose.
Show all 14Show fewer
- Highly variable vitamin intake.
- Unstable use of systemic or topical medications known to create dry eye.
- Corneal pathology, which could, of itself, cause an ocular surface disorder.
- Use of glaucoma medications, topical or oral.
- Unstable diabetes mellitus.
- Allergy or sensitivity to Lotemax, Restasis or the OTC Tear Supplement.
- Use of topical steroids or Restasis within the past 1 month.
- Use of other topical ocular agents other than tear replacements within the past 1 week.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Study of the Effect of Lotepredol Etabonate on The Initiation of Dry Eye Treatment With Topical Cyclosporine
To evaluate the impact of Lotemax on the initiation of Restasis therapy in patients with dry eye.
It is hypothesized that the anti-inflammatory activity of Lotemax may help mitigate the stinging with cyclosporine administration and the dry eye signs and symptoms experienced during the initiation of therapy.
Read the detailed description
Dry eye is an ocular surface disease that produces discomfort and irritation. Estimated prevalence ranges from 20 million people in the US being affected with mild to moderate dry eye, to as many as one out of every five Americans.
A growing body of evidence has associated ocular inflammation with the signs and symptoms of dry eye.
Restasis is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with a condition called keratoconjunctivitis sicca. The relief of dry eye signs and symptoms with Restasis therapy is often delayed by 1 to 6 months from the initiation of therapy. Stinging on installation, particularly when initiating therapy, has been reported.
Lotemax, an ophthalmic corticosteroid, targets inflammation with a unique, site-active mechanism of action.Structural modifications associated with an ester ophthalmic steroid make Lotemax highly lipid soluble, enhancing penetration into cells and enabling Lotemax to exert anti-inflammatory activity within the eye. Lotemax is indicated for the treatment of steroid responsive inflammatory conditions associated with the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
- Conditions
- Dry Eye Disease, Keratoconjunctivitis Sicca
- Being tested
- Lotemax, Restasis
- Keywords
- Dry Eye Disease, Lotemax, Restasis, Loteprednol, Cyclosporine
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LotemaxDrug
RestasisDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Questionnnaire Results
Lissamine green staining
Fluorescein Staining
Schirmer testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2006 (estimated)
- Study startNov 2006
- Primary completionSep 2007
- Study completionSep 2007
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 Dry Eye DiseaseStudies 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
- Double blind
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophthalmic Consultants of Long Island
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Investigators
- Maria Howard, Study director, Ophthalmic Consultants of Long Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00407043
- Sponsor's protocol ID
- Donnenfeld Review 1
- Status last verified
- Jul 2011
- First submitted
- 30 Nov 2006
- Last updated
- 21 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sheppard JD, Donnenfeld ED, Holland EJ, Slonim CB, Solomon R, Solomon KD, McDonald MB, Perry HD, Lane SS, Pflugfelder SC, Samudre SS. Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%. Eye Contact Lens. 2014 Sep;40(5):289-96. doi: 10.1097/ICL.0000000000000049.
PubMed 25083776
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Study of the Effect of Lotepredol Etabonate on The Initiation of Dry Eye Treatment With Topical Cyclosporine
- ClinicalTrials.gov ID
- NCT00407043
- Acronym / sponsor ID
- Donnenfeld Review 1
- Conditions
- Dry Eye Disease, Keratoconjunctivitis Sicca
- Keywords
- Dry Eye Disease, Lotemax, Restasis, Loteprednol, Cyclosporine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Ophthalmic Consultants of Long IslandUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Nov 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 4 Dec 2006 (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.
To evaluate the impact of Lotemax on the initiation of Restasis therapy in patients with dry eye.
It is hypothesized that the anti-inflammatory activity of Lotemax may help mitigate the stinging with cyclosporine administration and the dry eye signs and symptoms experienced during the initiation of therapy.
Detailed description
Dry eye is an ocular surface disease that produces discomfort and irritation. Estimated prevalence ranges from 20 million people in the US being affected with mild to moderate dry eye, to as many as one out of every five Americans.
A growing body of evidence has associated ocular inflammation with the signs and symptoms of dry eye.
Restasis is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with a condition called keratoconjunctivitis sicca. The relief of dry eye signs and symptoms with Restasis therapy is often delayed by 1 to 6 months from the initiation of therapy. Stinging on installation, particularly when initiating therapy, has been reported.
Lotemax, an ophthalmic corticosteroid, targets inflammation with a unique, site-active mechanism of action.Structural modifications associated with an ester ophthalmic steroid make Lotemax highly lipid soluble, enhancing penetration into cells and enabling Lotemax to exert anti-inflammatory activity within the eye. Lotemax is indicated for the treatment of steroid responsive inflammatory conditions associated with the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between the ages of 30 and 80 inclusive.
- Has not worn contact lenses for at least 1 month prior to the study and agrees to not wear contact lenses during study.
- Oral medications stable 1 month prior to study.
- Oral medications anticipated to be stable during 60 day study.
- Patient is in generally good \& stable overall health.
Key exclusion criteria (14 listed)
- History of Stevens-Johnson Syndrome or Ocular Pemphigoid.
- Punctal plugs inserted or punctal cautery in the past 3 months.
- Intra-ocular surgery within 6 months or ocular laser surgery within 3 months.
- History of liver disease.
- Pregnant or lactating women.
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 |
|---|---|---|
| Lotemax | Drug | – |
| Restasis | Drug | – |
Primary outcome
Ocular Surface Disease Questionnnaire Results
Lissamine green staining
Fluorescein Staining
Schirmer testing
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 Jul 2011.
- Derived from this study: PubMed 25083776Sheppard JD, Donnenfeld ED, Holland EJ, Slonim CB, Solomon R, Solomon KD, McDonald MB, Perry HD, Lane SS, Pflugfelder SC, Samudre SS. Effect of loteprednol etabonate 0.5% on initiation of dry eye treatment with topical cyclosporine 0.05%. Eye Contact Lens. 2014 Sep;40(5):289-96. doi: 10.1097/ICL.0000000000000049.
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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.
Maria Howard study director
Ophthalmic Consultants of Long Island
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 Lotemax and Restasis in people with Dry Eye Disease and Keratoconjunctivitis Sicca, run by Ophthalmic Consultants of Long Island 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 8 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 Jul 2011. 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.
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?
Ocular Surface Disease Questionnnaire Results. The study lists 4 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 NCT00407043, 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 21 Jul 2011.