AmetropiaPhase 2/3NCT00691197
Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
A Phase 2/3 study testing Carboxymethylcellulose sodium and Glycerin and Carboxymethylcellulose sodium in people with Ametropia, run by Allergan at 1 site in United States.
Trial summary
Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ametropia
- What is being tested?
- Carboxymethylcellulose sodium and Glycerin and Carboxymethylcellulose sodium
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Oct 2008
- Phase
- Phase 2/3
- 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
- Adapted contact lens wearer
Who cannot join
- Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses
- Conditions
- Ametropia
- Being tested
- Carboxymethylcellulose sodium and Glycerin, Carboxymethylcellulose sodium
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboxymethylcellulose sodium and GlycerinDevice
Also called Optive™
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Carboxymethylcellulose sodiumDevice
Also called Refresh Contacts®
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
| Study group | Role | What they receive |
|---|---|---|
| Carboxymethylcellulose sodium and Glycerin | Experimental | Carboxymethylcellulose sodium and Glycerin based rewetting drop Receives: Device: Carboxymethylcellulose sodium and Glycerin |
| Carboxymethylcellulose sodium | Active comparator | Carboxymethylcellulose sodium based rewetting drop Receives: Device: Carboxymethylcellulose sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity
Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.
Measured: Change from Baseline at Day 90
Secondary outcomes (1)
Corneal Staining
Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2008
- Study completionOct 2008
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 AmetropiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study chair, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691197
- Sponsor's protocol ID
- AG9689-002
- Status last verified
- Jun 2015
- First submitted
- 4 Mar 2008
- Last updated
- 22 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear
- ClinicalTrials.gov ID
- NCT00691197
- Acronym / sponsor ID
- AG9689-002
- Conditions
- Ametropia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Posted 10 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carboxymethylcellulose sodium and Glycerin | Experimental | Device: Carboxymethylcellulose sodium and GlycerinCarboxymethylcellulose sodium and Glycerin based rewetting drop |
| Carboxymethylcellulose sodium | Active comparator | Device: Carboxymethylcellulose sodiumCarboxymethylcellulose sodium based rewetting drop |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adapted contact lens wearer
Key exclusion criteria (1 listed)
- Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant
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 |
|---|---|---|
| Carboxymethylcellulose sodium and GlycerinAlso: Optive™Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses. | Device | Carboxymethylcellulose sodium and Glycerin |
| Carboxymethylcellulose sodiumAlso: Refresh Contacts®Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses. | Device | Carboxymethylcellulose sodium |
Primary outcome
Best Corrected Visual Acuity
Time frame: Change from Baseline at Day 90
Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.
1 secondary outcome
Corneal Staining
Time frame: Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial
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A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses
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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.
Medical Director study chair
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Carboxymethylcellulose sodium and Glycerin and Carboxymethylcellulose sodium in people with Ametropia, run by Allergan 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 1 inclusion and 1 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 22 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2009). 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?
Best Corrected Visual Acuity (time frame: Change from Baseline at Day 90). 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 22 Jul 2015.