MyopiaPhase 4NCT00627302
Efficacy of PEG-400 and Systane Artificial Tears (Alcon) on Quality of Vision
A Phase 4 study testing PEG-400 and Systane in people with Myopia, run by Bp Consulting, Inc at 1 site in United States.
Trial summary
To evaluate the effect of PEG-400 and Systane on quality of vision after LASIK. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- PEG-400 and Systane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Nov 2008
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females > 21 years old
- Scheduled to undergo bilateral LASIK
- Likely to complete all study visits and able to provide informed consent
Who cannot join
- Prior or current use of topical cyclosporine within the last 1 year
- Known contraindications to any study medication or ingredients
- Ocular disorders
- Active ocular diseases or uncontrolled systemic disease
- Active ocular allergies
- Complications at the time of surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Ophthalmic Consultants of long Island
Rockville Centre, New York, 11570
About this study
To evaluate the effect of PEG-400 and Systane on quality of vision after LASIK.
- Conditions
- Myopia
- Being tested
- PEG-400, Systane
- Keywords
- Quality of Vision
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-400Drug
Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily
SystaneDrug
Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily
| Study group | Role | What they receive |
|---|---|---|
| 2 | Active comparator | Systane Receives: Drug: Systane |
| 1 | Active comparator | PEG-400 Receives: Drug: PEG-400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of vision
Measured: 5 months
Secondary outcomes (1)
Efficacy
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bp Consulting, Inc
- Sponsor type
- Research network
- Investigators
- Eric Donnenfeld, MD, Principal investigator, Ophthalmic Consultants of Long Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627302
- Sponsor's protocol ID
- 5353
- Status last verified
- Nov 2008
- First submitted
- 22 Feb 2008
- Last updated
- 24 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of PEG-400 and Systane Artificial Tears (Alcon) on Quality of Vision
- ClinicalTrials.gov ID
- NCT00627302
- Acronym / sponsor ID
- 5353
- Conditions
- Myopia
- Keywords
- Quality of Vision
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bp Consulting, IncResearch network
- Study start
- Feb 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 3 Mar 2008 (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.
To evaluate the effect of PEG-400 and Systane on quality of vision after LASIK.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Active comparator | Drug: SystaneSystane |
| 1 | Active comparator | Drug: PEG-400PEG-400 |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females > 21 years old
- Scheduled to undergo bilateral LASIK
- Likely to complete all study visits and able to provide informed consent
Key exclusion criteria (6 listed)
- Prior or current use of topical cyclosporine within the last 1 year
- Known contraindications to any study medication or ingredients
- Ocular disorders
- Active ocular diseases or uncontrolled systemic disease
- Active ocular allergies
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 |
|---|---|---|
| PEG-400Day of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily | Drug | 1 |
| SystaneDay of Surgery: Starting 2 hours after surgery Instill one drop in randomized eye every two hours. Day 1-Week 1: Instill one drop in randomized eye four times daily | Drug | 2 |
Primary outcome
Quality of vision
Time frame: 5 months
1 secondary outcome
Efficacy
Time frame: 5 months
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 24 Nov 2008.
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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.
Eric Donnenfeld, MD principal investigator
Ophthalmic Consultants of Long Island
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 PEG-400 and Systane in people with Myopia, run by Bp Consulting, Inc 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 3 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 24 Nov 2008. 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?
Quality of vision (time frame: 5 months). 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 24 Nov 2008; AzTrials last refreshed its copy on 8 Nov 2026.