Contact Lens LubricationPhase 3NCT01844388
A Study to Compare a New Eye Drop Formulation With Refresh Contacts®
A Phase 3 study testing carboxymethylcellulose based eye drop formula and carboxymethylcellulose sodium based eye drop solution in people with Contact Lens Lubrication, run by Allergan at 1 site in United States.
Trial summary
This study will compare the safety and efficacy of a new carboxymethylcellulose based eye drop formula to Refresh Contacts® for lubricating and rewetting 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
- Contact Lens Lubrication
- What is being tested?
- carboxymethylcellulose based eye drop formula and carboxymethylcellulose sodium based eye drop solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2013to 2 Dec 2013
- Phase
- Phase 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 wearer with daily usage of at least 6 hours a day, 5 days a week.
Who cannot join
- Wearing monovision lenses
- Have had refractive surgery within the previous 12 months
- Have infection of the eye, eyelids or eye structures.
Trial locations and contacts
1 site in 1 country.
About this study
This study will compare the safety and efficacy of a new carboxymethylcellulose based eye drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.
- Conditions
- Contact Lens Lubrication
- Being tested
- carboxymethylcellulose based eye drop formula, carboxymethylcellulose sodium based eye drop solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboxymethylcellulose based eye drop formulaDrug
1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
carboxymethylcellulose sodium based eye drop solutionDrug
Also called REFRESH CONTACTS®
1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
| Study group | Role | What they receive |
|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formula | Experimental | 1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion. Receives: Drug: carboxymethylcellulose based eye drop formula |
| REFRESH CONTACTS® | Active comparator | 1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion. Receives: Drug: carboxymethylcellulose sodium based eye drop solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.
Measured: Baseline, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2013 (estimated)
- Study start29 May 2013
- Primary completion2 Dec 2013
- Study completion2 Dec 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contact Lens LubricationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01844388
- Sponsor's protocol ID
- 10077X-001
- Status last verified
- Apr 2019
- First submitted
- 29 Apr 2013
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Nichols JJ, Lievens CW, Bloomenstein MR, Liu H, Simmons P, Vehige J. Dual-Polymer Drops, Contact Lens Comfort, and Lid Wiper Epitheliopathy. Optom Vis Sci. 2016 Aug;93(8):979-86. doi: 10.1097/OPX.0000000000000878.
PubMed 27254807
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare a New Eye Drop Formulation With Refresh Contacts®
- ClinicalTrials.gov ID
- NCT01844388
- Acronym / sponsor ID
- 10077X-001
- Conditions
- Contact Lens Lubrication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 29 May 2013 (actual)
- Primary completion
- 2 Dec 2013 (actual)
- Study completion
- 2 Dec 2013 (actual)
- First posted
- 1 May 2013 (estimated)
- Results
- Posted 29 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare the safety and efficacy of a new carboxymethylcellulose based eye drop formula to Refresh Contacts® for lubricating and rewetting contact lenses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carboxymethylcellulose Based Eye Drop Formula | Experimental | Drug: carboxymethylcellulose based eye drop formula1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion. |
| REFRESH CONTACTS® | Active comparator | Drug: carboxymethylcellulose sodium based eye drop solution1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion. |
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 wearer with daily usage of at least 6 hours a day, 5 days a week.
Key exclusion criteria (3 listed)
- Wearing monovision lenses
- Have had refractive surgery within the previous 12 months
- Have infection of the eye, eyelids or eye structures.
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 based eye drop formula1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion. | Drug | Carboxymethylcellulose Based Eye Drop Formula |
| carboxymethylcellulose sodium based eye drop solutionAlso: REFRESH CONTACTS®1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion. | Drug | REFRESH CONTACTS® |
Primary outcome
Percentage of Participants With Contact Lens Distance Visual Acuity Change From Baseline
Time frame: Baseline, Day 90
Contact lens distance visual acuity was measured for each eye using the LogMAR visual acuity eye chart. The worse eye at Baseline was used for analysis. A change of 0.1 on the LogMAR scale was equivalent to a 1 line change in visual acuity. The following categories are reported: Better=an increase in 2 or more lines, No Change=a change of +/- 1 line, and Worse=a decrease of 2 lines or more.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27254807Nichols JJ, Lievens CW, Bloomenstein MR, Liu H, Simmons P, Vehige J. Dual-Polymer Drops, Contact Lens Comfort, and Lid Wiper Epitheliopathy. Optom Vis Sci. 2016 Aug;93(8):979-86. doi: 10.1097/OPX.0000000000000878.
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 director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carboxymethylcellulose based eye drop formula and carboxymethylcellulose sodium based eye drop solution in people with Contact Lens Lubrication, 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 3 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 16 Apr 2019. 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 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 29 Sep 2014). 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 Participants With Contact Lens Distance Visual Acuity Change From Baseline (time frame: Baseline, Day 90). 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 NCT01844388, 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 16 Apr 2019.