Bilateral LASIK SurgeryPhase 3NCT01886690
A Study to Compare the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery
A Phase 3 study testing carboxymethylcellulose sodium based new eye drop formulation and carboxymethylcellulose sodium based eye drops in people with Bilateral LASIK Surgery, run by Allergan at 2 sites in 2 countries.
Trial summary
This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bilateral LASIK Surgery
- What is being tested?
- carboxymethylcellulose sodium based new eye drop formulation and carboxymethylcellulose sodium based eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Aug 2013to 18 Aug 2014
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -Patients scheduled for LASIK surgery in both eyes.
Who cannot join
- Any systemic medication use within 3 months of screening (including over the counter, herbal, prescription, or nutritional supplement) which may affect dry eye or vision
- Use of topical eye medication other than prescribed for use in pre- or post-operative care
- Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months prior to Screening
- Eye infection, inflammation, or allergy
- Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30 days prior to LASIK surgery.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This study will compare the safety and efficacy of a new eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.
- Conditions
- Bilateral LASIK Surgery
- Being tested
- carboxymethylcellulose sodium based new eye drop formulation, carboxymethylcellulose sodium based eye drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carboxymethylcellulose sodium based new eye drop formulationDrug
1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
carboxymethylcellulose sodium based eye dropsDrug
Also called REFRESH PLUS®
1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| New Eye Drop Formulation | Experimental | 1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days. Receives: Drug: carboxymethylcellulose sodium based new eye drop formulation |
| REFRESH PLUS® | Active comparator | 1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days. Receives: Drug: carboxymethylcellulose sodium based eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale
The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability).
Measured: Day 90
Secondary outcomes (4)
Change From Baseline in Corneal Staining in the Worse Eye
The cornea is the transparent front part of the eye which covers the iris and pupil. Corneal staining in the worse eye following administration of fluorescein dye in the eye is graded using a 6-point scale (0=no staining, 5=severe staining) over 5 areas of the clear central part of the eye for a minimum score of 0 and maximum score of 25. The higher the grade score, the worse the dry eye condition. A negative change from baseline represents a decrease in corneal staining (improvement) and a positive change from baseline represents an increase in corneal staining (worsening).
Measured: Baseline, Day 90
Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye
TBUT is the time required for dry spots to appear on the surface of the eye after blinking in the worse eye. The longer it takes, the more stable the tear film. A short TBUT is a sign of poor tear film. A positive number change from baseline indicates an increase in TBUT (improvement) and a negative number change from baseline indicates a decrease in TBUT (worsening).
Measured: Baseline, Day 90
Change From Baseline in the Schirmer Test in the Worse Eye
The Schirmer's Test measures the rate of the secretion of tears produced by the eye over 5 minutes in the worse eye. The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye. A positive number change from baseline indicates an increase in tears (improvement) and a negative number change from baseline indicates a decrease in tears (worsening).
Measured: Baseline, Day 90
Change From Baseline in Uncorrected Visual Acuity in the Worse Eye
Uncorrected visual acuity in the worse eye is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) without corrective lenses. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive number change from baseline in the number of letters read correctly indicates an improvement and a negative number change from baseline indicates a worsening.
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 posted26 Jun 2013 (estimated)
- Study start20 Aug 2013
- Primary completion18 Aug 2014
- Study completion18 Aug 2014
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 Bilateral LASIK SurgeryStudies 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
- 148 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
- NCT01886690
- Sponsor's protocol ID
- 11002X-002
- Status last verified
- Apr 2019
- First submitted
- 24 Jun 2013
- Last updated
- 16 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wallerstein A, Jackson WB, Chambers J, Moezzi AM, Lin H, Simmons PA. Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose. Clin Ophthalmol. 2018 May 7;12:839-848. doi: 10.2147/OPTH.S163744. eCollection 2018.
PubMed 29765198
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 the Safety and Efficacy of a New Eye Drop Formulation With REFRESH PLUS® in Participants Following LASIK Refractive Surgery
- ClinicalTrials.gov ID
- NCT01886690
- Acronym / sponsor ID
- 11002X-002
- Conditions
- Bilateral LASIK Surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2013 (actual)
- Primary completion
- 18 Aug 2014 (actual)
- Study completion
- 18 Aug 2014 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Posted 5 Oct 2015
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 eye drop formulation with REFRESH PLUS® in participants following LASIK surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Eye Drop Formulation | Experimental | Drug: carboxymethylcellulose sodium based new eye drop formulation1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days. |
| REFRESH PLUS® | Active comparator | Drug: carboxymethylcellulose sodium based eye drops1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Patients scheduled for LASIK surgery in both eyes.
Key exclusion criteria (5 listed)
- Any systemic medication use within 3 months of screening (including over the counter, herbal, prescription, or nutritional supplement) which may affect dry eye or vision
- Use of topical eye medication other than prescribed for use in pre- or post-operative care
- Use of RESTASIS® or other topical ophthalmic cyclosporine product within 6 months prior to Screening
- Eye infection, inflammation, or allergy
- Soft contact lenses in the previous 7 days or rigid contact lenses in the previous 30 days prior to LASIK surgery.
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 based new eye drop formulation1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days. | Drug | New Eye Drop Formulation |
| carboxymethylcellulose sodium based eye dropsAlso: REFRESH PLUS®1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days. | Drug | REFRESH PLUS® |
Primary outcome
Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale
Time frame: Day 90
The OSDI© is a 12-question survey for patients to document their dry eye disease symptoms. Each question is rated on a 5-point scale (0=none of the time and 4 = all of the time). The scores are totaled over the 12 questions and normalized/converted to a score of 0-100 (0=no disability and 100=complete disability).
4 secondary outcomes
Change From Baseline in Corneal Staining in the Worse Eye
Time frame: Baseline, Day 90
Change From Baseline in Tear Break-up Time (TBUT) in the Worse Eye
Time frame: Baseline, Day 90
Change From Baseline in the Schirmer Test in the Worse Eye
Time frame: Baseline, Day 90
Change From Baseline in Uncorrected Visual Acuity in the Worse Eye
Time frame: Baseline, Day 90
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 29765198Wallerstein A, Jackson WB, Chambers J, Moezzi AM, Lin H, Simmons PA. Management of post-LASIK dry eye: a multicenter randomized comparison of a new multi-ingredient artificial tear to carboxymethylcellulose. Clin Ophthalmol. 2018 May 7;12:839-848. doi: 10.2147/OPTH.S163744. eCollection 2018.
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
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing carboxymethylcellulose sodium based new eye drop formulation and carboxymethylcellulose sodium based eye drops in people with Bilateral LASIK Surgery, run by Allergan at 2 sites in 2 countries.
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 5 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 2 sites in Australia, Canada. 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 5 Oct 2015). 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?
Ocular Surface Disease Index© (OSDI) Score Using a 5-Point Scale (time frame: 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 NCT01886690, 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.