Dry EyeNCT01267656
Study to Evaluate a Contact Lens Lubricating and Rewetting Drop
A study testing Lubricating and Rewetting Drops and AMO Blink Contacts Lubricant Eye Drops in people with Dry Eye, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Lubricating and Rewetting Drops and AMO Blink Contacts Lubricant Eye Drops
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Use a lens care system on a regular basis.
- Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.
- Willing to use drops 4 times per day.
Who cannot join
- Participating in a conflicting study.
- An active ocular disease, any corneal infiltrative response, or are using any ocular medications.
- Any scar or neovascularization within the central 4mm of the cornea.
- Any grade 2 or greater finding during the slit lamp examination
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
- Aphakic.
Show all 9Show fewer
- Amblyopic.
- Allergic to any component in the study care products.
- Have had any corneal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study to Evaluate the Product Feasibility of a Contact Lens Lubricating and Rewetting Drop
The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.
- Conditions
- Dry Eye
- Being tested
- Lubricating and Rewetting Drops, AMO Blink Contacts Lubricant Eye Drops
- Keywords
- rewetting, lubricating, eye drops
- 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.
Lubricating and Rewetting DropsDevice
Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
AMO Blink Contacts Lubricant Eye DropsDevice
Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
| Study group | Role | What they receive |
|---|---|---|
| Lubricating and Rewetting Drops | Experimental | Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week. Receives: Device: Lubricating and Rewetting Drops |
| AMO Blink Contacts Lubricant Eye Drops | Active comparator | AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week Receives: Device: AMO Blink Contacts Lubricant Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.
Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding > grade 2, across abnormalities.
Measured: At 1 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry EyeStudies 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephanie Su, OD, Principal investigator, Bausch & Lomb Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267656
- Sponsor's protocol ID
- 684E
- Status last verified
- Sep 2020
- First submitted
- 27 Dec 2010
- Last updated
- 30 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Product Feasibility of a Contact Lens Lubricating and Rewetting Drop
- ClinicalTrials.gov ID
- NCT01267656
- Acronym / sponsor ID
- 684E
- Conditions
- Dry Eye
- Keywords
- rewetting, lubricating, eye drops
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Dec 2010 (estimated)
- Results
- Posted 30 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lubricating and Rewetting Drops | Experimental | Device: Lubricating and Rewetting DropsLubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week. |
| AMO Blink Contacts Lubricant Eye Drops | Active comparator | Device: AMO Blink Contacts Lubricant Eye DropsAMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Use a lens care system on a regular basis.
- Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.
- Willing to use drops 4 times per day.
Key exclusion criteria (9 listed)
- Participating in a conflicting study.
- An active ocular disease, any corneal infiltrative response, or are using any ocular medications.
- Any scar or neovascularization within the central 4mm of the cornea.
- Any grade 2 or greater finding during the slit lamp examination
- Using any systemic or topical medications that will affect ocular physiology or lens performance.
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 |
|---|---|---|
| Lubricating and Rewetting DropsInstill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week. | Device | Lubricating and Rewetting Drops |
| AMO Blink Contacts Lubricant Eye DropsInstill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week. | Device | AMO Blink Contacts Lubricant Eye Drops |
Primary outcome
Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.
Time frame: At 1 week follow up
Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding > grade 2, across abnormalities.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Stephanie Su, OD principal investigator
Bausch & Lomb Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lubricating and Rewetting Drops and AMO Blink Contacts Lubricant Eye Drops in people with Dry Eye, run by Bausch & Lomb Incorporated 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 5 inclusion and 9 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 30 Sep 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2. (time frame: At 1 week follow up). 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 30 Sep 2020.