Dry Eye DiseasePhase 4NCT02028312
A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis®
A Phase 4 study testing Loteprednol etabonate, Artificial Tears and Restasis in people with Dry Eye Disease, run by Edward Holland, MD at 1 site in United States.
Trial summary
A pilot study to evaluate the impact of Lotemax® Gel (loteprednol etabonate ophthalmic gel 0.5%) on the initiation of Restasis® (cyclosporine ophthalmic emulsion 0.05%) therapy in subjects with dry eye. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Loteprednol etabonate, Artificial Tears and Restasis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2016
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent prior to any study-related procedures and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Are between the ages of 21 and 80 inclusive.
- Have not worn contact lenses for at least 1 month prior to the study and agrees not to wear contact lenses during the study.
- Have been on stable oral medications for 1 month prior to the study.
- Are in generally good and stable overall health.
- Are a woman of child bearing potential (WOCBP) who is not pregnant or lactating and not sexually active (i.e. abstinent) at Visit 1 and willing to remain so through Visit 4. Alternatively, a WOCBP who is not abstinent must have been using an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study.
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- Are women who have undergone one of the following sterilization procedures at least 1 month prior to Visit 1:
- Bilateral tubal ligation
- Hysterectomy
- Hysterectomy with unilateral or bilateral oophorectomy.
- Bilateral oophorectomy
- Are likely to comply with the eye drop regime, study guidelines, and study visits.
Who cannot join
- Have a history of Stevens-Johnson Syndrome or ocular pemphigoid.
- Have had punctual plugs inserted or removed; or punctual cautery 3 months prior to Visit 1/Screening and Baseline Visit and throughout the study.
- Have had intra-ocular surgery within 6 months prior to the Visit 1/Screening and Baseline Visit.
- Have a history of liver disease.
- Be pregnant or lactating.
- Have severe clinical vitamin deficiencies or a history of vitamin overdose.
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- Have a highly variable vitamin intake.
- Wear contact lenses.
- Have unstable use of systemic or topical medications known to create dry eye.
- Have corneal pathology, which could, of itself, cause an ocular surface disorder.
- Have used glaucoma medications, topical or oral within 30 days of Visit 1/Screening and Baseline Visit.
- Have unstable diabetes mellitus.
- Have an allergy or sensitivity to Lotemax® Gel, Restasis®, or non-preservative artificial tears.
- Have used topical steroids or Restasis® within 1 month prior to the Screening and Baseline Visit and throughout the study, except the study medication provided per the protocol.
- Have a condition for which steroid use would be contraindicated (e.g. viral infection).
- Use other topical ocular agents other than tear replacements within 1 week prior to the Screening and Baseline Visit and throughout the study.
- Have been exposed to an investigational drug within the preceding 30 days.
- In the opinion of the investigator or study coordinator, be unwilling or unable to comply with the study protocol or unable to successfully instill eye drops.
Trial locations and contacts
1 site in 1 country.
About this study
A pilot study to evaluate the impact of Lotemax® Gel (loteprednol etabonate ophthalmic gel 0.5%) on the initiation of Restasis® (cyclosporine ophthalmic emulsion 0.05%) therapy in subjects with dry eye.
- Conditions
- Dry Eye Disease
- Being tested
- Loteprednol etabonate, Artificial Tears, Restasis
- Keywords
- Dry Eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loteprednol etabonateDrug
Artificial TearsDrug
RestasisDrug
| Study group | Role | What they receive |
|---|---|---|
| Loteprednol etabonate + Restasis | Active comparator | Loteprednol Etabonate Ophthalmic Gel 0.5%, BID 30 days Restasis, BID 45 days Receives: Drug: Loteprednol etabonate; Drug: Restasis |
| Artificial Tears + Restasis | Placebo comparator | Artificial Tears, BID 30 days Restasis, BID 45 days Receives: Drug: Artificial Tears; Drug: Restasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescein corneal staining scores
Measured: 60 Days
Secondary outcomes (1)
Lissamine green conjunctival staining
Measured: 60 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2016 (estimated)
- Study completionJun 2016 (estimated)
Why it stopped: Per Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward Holland, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edward Holland, MD, Holprovision
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028312
- Sponsor's protocol ID
- CEI.HER-002
- Status last verified
- Mar 2015
- First submitted
- 3 Jan 2014
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis®
- ClinicalTrials.gov ID
- NCT02028312
- Acronym / sponsor ID
- CEI.HER-002
- Conditions
- Dry Eye Disease
- Keywords
- Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Per Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Edward Holland, MDUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 7 Jan 2014 (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.
A pilot study to evaluate the impact of Lotemax® Gel (loteprednol etabonate ophthalmic gel 0.5%) on the initiation of Restasis® (cyclosporine ophthalmic emulsion 0.05%) therapy in subjects with dry eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Loteprednol etabonate + Restasis | Active comparator | Drug: Loteprednol etabonate, Drug: RestasisLoteprednol Etabonate Ophthalmic Gel 0.5%, BID 30 days Restasis, BID 45 days |
| Artificial Tears + Restasis | Placebo comparator | Drug: Artificial Tears, Drug: RestasisArtificial Tears, BID 30 days Restasis, BID 45 days |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Provide written informed consent prior to any study-related procedures and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Are between the ages of 21 and 80 inclusive.
- Have not worn contact lenses for at least 1 month prior to the study and agrees not to wear contact lenses during the study.
- Have been on stable oral medications for 1 month prior to the study.
- Are in generally good and stable overall health.
Key exclusion criteria (18 listed)
- Have a history of Stevens-Johnson Syndrome or ocular pemphigoid.
- Have had punctual plugs inserted or removed; or punctual cautery 3 months prior to Visit 1/Screening and Baseline Visit and throughout the study.
- Have had intra-ocular surgery within 6 months prior to the Visit 1/Screening and Baseline Visit.
- Have a history of liver disease.
- Be pregnant or lactating.
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 | Drug | Loteprednol etabonate + Restasis |
| Artificial Tears | Drug | Artificial Tears + Restasis |
| Restasis | Drug | Artificial Tears + Restasis, Loteprednol etabonate + Restasis |
Primary outcome
Fluorescein corneal staining scores
Time frame: 60 Days
1 secondary outcome
Lissamine green conjunctival staining
Time frame: 60 Days
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 18 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Loteprednol etabonate, Artificial Tears and Restasis in people with Dry Eye Disease, run by Edward Holland, MD 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 12 inclusion and 18 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 18 Mar 2015. 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. 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.
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 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?
Fluorescein corneal staining scores (time frame: 60 Days). 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 18 Mar 2015.