Allergic ConjunctivitisPhase 4NCT00489398
Comparison of CL Wear Between Two Allergy Drops
A Phase 4 study testing epinastine HCL and olopatadine HCL in people with Allergic Conjunctivitis, run by Hom, Milton M., OD, FAAO.
Trial summary
Comparison of two allergy drops for enhancing comfort and performance of contact lens wear Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- epinastine HCL and olopatadine HCL
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Dec 2008
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females > 18 years old
- Mild to moderate dry eye symptoms
- Likely to complete all study visits and able to provide informed consent
Who cannot join
- Current use of topical cyclosporine
- Known contraindications to any study medication or ingredients
- Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
- Ocular surgery within the past 3 months
About this study
Official title: Comparison of CL Wear Between Epinastine Hydrochloride and Olopatadine Hydrochloride
Comparison of two allergy drops for enhancing comfort and performance of contact lens wear
Read the detailed description
Contact lens patients will instill allergy drops and subjective and objective tests will be performed
- Conditions
- Allergic Conjunctivitis
- Being tested
- epinastine HCL and olopatadine HCL
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epinastine HCL and olopatadine HCLDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Contact lens objective and subjective clinical performance testing
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startJul 2007
- Study completionDec 2008 (estimated)
Why it stopped: Protocol changes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic ConjunctivitisStudies 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
- Crossover
- Masking
- Single blind
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hom, Milton M., OD, FAAO
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Milton M Hom, OD FAAO, Study director, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489398
- Sponsor's protocol ID
- 5316
- Status last verified
- Oct 2010
- First submitted
- 19 Jun 2007
- Last updated
- 7 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of CL Wear Between Epinastine Hydrochloride and Olopatadine Hydrochloride
- ClinicalTrials.gov ID
- NCT00489398
- Acronym / sponsor ID
- 5316
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol changes
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Hom, Milton M., OD, FAAO
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jul 2007
- Study completion
- Dec 2008 (estimated)
- First posted
- 21 Jun 2007 (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.
Comparison of two allergy drops for enhancing comfort and performance of contact lens wear
Detailed description
Contact lens patients will instill allergy drops and subjective and objective tests will be performed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females > 18 years old
- Mild to moderate dry eye symptoms
- Likely to complete all study visits and able to provide informed consent
Key exclusion criteria (4 listed)
- Current use of topical cyclosporine
- Known contraindications to any study medication or ingredients
- Active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable)
- Ocular surgery within the past 3 months
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 |
|---|---|---|
| epinastine HCL and olopatadine HCL | Drug | – |
Primary outcome
Contact lens objective and subjective clinical performance testing
Time frame: up to 3 months
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 7 Oct 2010.
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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.
Milton M Hom, OD FAAO study director
Private Practice
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing epinastine HCL and olopatadine HCL in people with Allergic Conjunctivitis, run by Hom, Milton M., OD, FAAO.
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 3 inclusion and 4 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 7 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Contact lens objective and subjective clinical performance testing (time frame: up to 3 months). 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 7 Oct 2010.