Eye DiseasesPhase 3NCT00333203
Next Generation Ophthalmic Irrigating Solution Posterior Segment Study
A Phase 3 study testing Next Generation Ophthalmic Irrigating Solution (NGOIS) and BSS Plus in people with Eye Diseases, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular membrane and vitrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Diseases
- What is being tested?
- Next Generation Ophthalmic Irrigating Solution (NGOIS) and BSS Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 369 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Mar 2006
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of any race and sex, with an epimacular membrane who would benefit from vitrectomy and membrane removal.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Under 18 years of age.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of the Safety of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Surgery for Removal of Epimacular Membrane and Vitrectomy
The purpose of this study is to evaluate the safety of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular membrane and vitrectomy.
- Conditions
- Eye Diseases
- Being tested
- Next Generation Ophthalmic Irrigating Solution (NGOIS), BSS Plus
- Keywords
- epimacular membrane
- Medical subject headings
- Eye Diseases, Epiretinal Membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Generation Ophthalmic Irrigating Solution (NGOIS)Drug
Volume sufficient to irrigate adequately during cataract surgery
BSS PlusOther
Volume sufficient to irrigate adequately during cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| NGOIS | Experimental | Not described Receives: Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS) |
| BSS Plus | Active comparator | Not described Receives: Other: BSS Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected logMAR visual acuity
Secondary outcomes (1)
Intraocular pressure (IOP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2006 (estimated)
- Study startOct 2005
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies 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
- Single blind
- Enrolment
- 369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00333203
- Sponsor's protocol ID
- C-04-18
- Status last verified
- Mar 2012
- First submitted
- 1 Jun 2006
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety of Next Generation Ophthalmic Irrigating Solution Compared to BSS Plus for Use During Surgery for Removal of Epimacular Membrane and Vitrectomy
- ClinicalTrials.gov ID
- NCT00333203
- Acronym / sponsor ID
- C-04-18
- Conditions
- Eye Diseases
- Keywords
- epimacular membrane
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 369 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 2 Jun 2006 (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.
The purpose of this study is to evaluate the safety of Next Generation Ophthalmic Irrigating Solution (NGOIS) compared to BSS PLUS for use during surgery for removal of epimacular membrane and vitrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NGOIS | Experimental | Drug: Next Generation Ophthalmic Irrigating Solution (NGOIS) |
| BSS Plus | Active comparator | Other: BSS Plus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of any race and sex, with an epimacular membrane who would benefit from vitrectomy and membrane removal.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (2 listed)
- Under 18 years of age.
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| Next Generation Ophthalmic Irrigating Solution (NGOIS)Volume sufficient to irrigate adequately during cataract surgery | Drug | NGOIS |
| BSS PlusVolume sufficient to irrigate adequately during cataract surgery | Other | BSS Plus |
Primary outcome
Best-corrected logMAR visual acuity
1 secondary outcome
Intraocular pressure (IOP)
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 5 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Next Generation Ophthalmic Irrigating Solution (NGOIS) and BSS Plus in people with Eye Diseases, run by Alcon Research 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 2 inclusion and 2 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 5 Mar 2012. 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?
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?
Best-corrected logMAR visual acuity. 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 5 Mar 2012.