Contact Lens Dry EyePhase 4NCT01105624
A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)
A Phase 4 study testing azithromycin ophthalmic solution, 1% and Visine® for Contacts® in people with Contact Lens Dry Eye, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The primary objective of this study is to compare the duration of subject reported comfortable contact lens daily wear time in subjects with a history and current complaint of CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to rewetting drops Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contact Lens Dry Eye
- What is being tested?
- azithromycin ophthalmic solution, 1% and Visine® for Contacts®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Nov 2010
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a history of and current complaint of CLDE.
- Use properly fitted daily-wear soft contact lenses.
- Able to wear contact lenses for at least 8 hours a day.
- If female, are non-pregnant or non-lactating.
Who cannot join
- Have changed brand of contact lens or care solutions within one month prior to Visit 1.
- Use extended (overnight) wear contact lenses.
- Have a clinically significant ophthalmic abnormality.
- Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening.
- Have any active ongoing ocular infection or ocular disease.
- Have a serious medical condition which could confound study assessments.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University, College of Optometry
Columbus, Ohio, 43210
About this study
The primary objective of this study is to compare the duration of subject reported comfortable contact lens daily wear time in subjects with a history and current complaint of CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to rewetting drops
- Conditions
- Contact Lens Dry Eye
- Being tested
- azithromycin ophthalmic solution, 1%, Visine® for Contacts®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
azithromycin ophthalmic solution, 1%Drug
1 drop BID for the first 2 days and then 1 drop QD for the remainder of treatment period (29 ± 1 day)
Visine® for Contacts®Drug
1-2 drops QID for the treatment period (29 ± 1 day)
| Study group | Role | What they receive |
|---|---|---|
| azithromycin ophthalmic solution, 1% | Experimental | Not described Receives: Drug: azithromycin ophthalmic solution, 1% |
| rewetting drops | Experimental | Not described Receives: Drug: Visine® for Contacts® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint
Measured: 4 weeks
Secondary outcomes (6)
Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint
Measured: 2 weeks
Subject-reported duration of total contact lens daily wear
Measured: 4 weeks
Subject-reported rating of overall eye dryness
Measured: 4 weeks
Contact Lens-Related Dry Eye Questionnaire
Measured: 4 weeks
Tear hyperosmolarity (mOsm)
Measured: 4 weeks
Habitual low-contrast visual acuity (LCVA)
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2010
- Study completionNov 2010
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 Contact Lens Dry EyeStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Reza Haque, MD, PhD, Study chair, Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105624
- Sponsor's protocol ID
- 041-117
- Other IDs
- P08644
- Status last verified
- Sep 2011
- First submitted
- 15 Apr 2010
- Last updated
- 26 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Nichols JJ, Bickle KM, Zink RC, Schiewe MD, Haque RM, Nichols KK. Safety and efficacy of topical azithromycin ophthalmic solution 1.0% in the treatment of contact lens-related dry eye. Eye Contact Lens. 2012 Mar;38(2):73-9. doi: 10.1097/ICL.0b013e31823ff229.
PubMed 22157392
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Rewetting Drops in Subjects With History and Current Complaint of Contact Lens-Related Dry Eye (CLDE)
- ClinicalTrials.gov ID
- NCT01105624
- Acronym / sponsor ID
- 041-117
- Conditions
- Contact Lens Dry Eye
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 16 Apr 2010 (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 primary objective of this study is to compare the duration of subject reported comfortable contact lens daily wear time in subjects with a history and current complaint of CLDE during a 29-day treatment period of azithromycin ophthalmic solution, 1%, compared to rewetting drops
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| azithromycin ophthalmic solution, 1% | Experimental | Drug: azithromycin ophthalmic solution, 1% |
| rewetting drops | Experimental | Drug: Visine® for Contacts® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a history of and current complaint of CLDE.
- Use properly fitted daily-wear soft contact lenses.
- Able to wear contact lenses for at least 8 hours a day.
- If female, are non-pregnant or non-lactating.
Key exclusion criteria (6 listed)
- Have changed brand of contact lens or care solutions within one month prior to Visit 1.
- Use extended (overnight) wear contact lenses.
- Have a clinically significant ophthalmic abnormality.
- Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening.
- Have any active ongoing ocular infection or ocular disease.
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 |
|---|---|---|
| azithromycin ophthalmic solution, 1%1 drop BID for the first 2 days and then 1 drop QD for the remainder of treatment period (29 ± 1 day) | Drug | azithromycin ophthalmic solution, 1% |
| Visine® for Contacts®1-2 drops QID for the treatment period (29 ± 1 day) | Drug | rewetting drops |
Primary outcome
Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint
Time frame: 4 weeks
6 secondary outcomes
Subject-reported comfortable contact lens daily wear time, excluding Week 4 Endpoint
Time frame: 2 weeks
Subject-reported duration of total contact lens daily wear
Time frame: 4 weeks
Subject-reported rating of overall eye dryness
Time frame: 4 weeks
Contact Lens-Related Dry Eye Questionnaire
Time frame: 4 weeks
Tear hyperosmolarity (mOsm)
Time frame: 4 weeks
Habitual low-contrast visual acuity (LCVA)
Time frame: 4 weeks
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 26 Sep 2011.
- Derived from this study: PubMed 22157392Nichols JJ, Bickle KM, Zink RC, Schiewe MD, Haque RM, Nichols KK. Safety and efficacy of topical azithromycin ophthalmic solution 1.0% in the treatment of contact lens-related dry eye. Eye Contact Lens. 2012 Mar;38(2):73-9. doi: 10.1097/ICL.0b013e31823ff229.
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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.
Reza Haque, MD, PhD study chair
Medical Monitor
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 azithromycin ophthalmic solution, 1% and Visine® for Contacts® in people with Contact Lens Dry Eye, run by Merck Sharp & Dohme LLC 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 4 inclusion and 6 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 26 Sep 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?
Subject-reported comfortable contact lens daily wear time (hours/day) at Week 4 Endpoint (time frame: 4 weeks). 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 NCT01105624, 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 26 Sep 2011.