Dry EyeNCT01833117
Efficacy and Safety Study of FID 119515A
A study testing FID 119515A and Blink® Tears in people with Dry Eye, run by Alcon Research.
Trial summary
The purpose of this study was to compare the effect of FID 119515A to Blink® Tears on the integrity of tear film in adults with a history of dry eye in both eyes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- FID 119515A and Blink® Tears
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- May 2013to Jun 2013
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign Informed Consent.
- Best corrected visual acuity (BCVA) of 55 or greater in each eye as measured by an ETDRS chart (letters read method).
- At least a 3 month documented history of dry eye in both eyes.
- TBUT and Ocular Surface Disease Index (OSDI) Questionnaire score as specified in protocol.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Pregnant or breastfeeding.
- Any evidence of ocular infection or inflammation within 30 days prior to Screening.
- Any ocular surgery.
- Ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
- Current presence of punctal plugs (permanent or temporary) or previous permanent punctal closure by cautery/diathermy.
- Use of topical ocular prescription or non-prescription medications within 30 days of Screening.
- Participation in any other clinical trial within 30 days prior to Screening.
- Other protocol-defined exclusion criteria may apply.
About this study
Official title: A Randomized, Observer-Masked, Efficacy and Safety Study of FID 119515A in Dry Eye
The purpose of this study was to compare the effect of FID 119515A to Blink® Tears on the integrity of tear film in adults with a history of dry eye in both eyes.
Read the detailed description
Subjects who met the enrollment criteria were randomized in a 2:1 manner to receive treatment with FID 119515A or Blink® Tears respectively for this 1-day, single-dose study.
- Conditions
- Dry Eye
- Being tested
- FID 119515A, Blink® Tears
- Keywords
- Dry eye, Tear film, Tear break-up time, Ocular surface, Eye drops
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FID 119515AOther
topical ocular drops
Blink® TearsOther
topical ocular drops
| Study group | Role | What they receive |
|---|---|---|
| FID 119515A | Experimental | FID 119515A, 1 drop instilled in the study eye, single dose Receives: Other: FID 119515A |
| Blink | Active comparator | Blink® Tears, 1 drop instilled in the study eye, single dose Receives: Other: Blink® Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes
Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.
Measured: Baseline, 60 minutes
Secondary outcomes (1)
Area Under Curve (AUC) of TBUT From 0 to 60 Minutes
Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 5, 15, 30, and 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.
Measured: 0 to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2013
- Study completionJun 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.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lisa Lindsey, PhD, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01833117
- Sponsor's protocol ID
- C-12-021
- Status last verified
- Apr 2014
- First submitted
- 12 Apr 2013
- Last updated
- 29 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Observer-Masked, Efficacy and Safety Study of FID 119515A in Dry Eye
- ClinicalTrials.gov ID
- NCT01833117
- Acronym / sponsor ID
- C-12-021
- Conditions
- Dry Eye
- Keywords
- Dry eye, Tear film, Tear break-up time, Ocular surface, Eye drops
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Apr 2013 (estimated)
- Results
- Posted 30 Jun 2014
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 was to compare the effect of FID 119515A to Blink® Tears on the integrity of tear film in adults with a history of dry eye in both eyes.
Detailed description
Subjects who met the enrollment criteria were randomized in a 2:1 manner to receive treatment with FID 119515A or Blink® Tears respectively for this 1-day, single-dose study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FID 119515A | Experimental | Other: FID 119515AFID 119515A, 1 drop instilled in the study eye, single dose |
| Blink | Active comparator | Other: Blink® TearsBlink® Tears, 1 drop instilled in the study eye, single dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Sign Informed Consent.
- Best corrected visual acuity (BCVA) of 55 or greater in each eye as measured by an ETDRS chart (letters read method).
- At least a 3 month documented history of dry eye in both eyes.
- TBUT and Ocular Surface Disease Index (OSDI) Questionnaire score as specified in protocol.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (8 listed)
- Pregnant or breastfeeding.
- Any evidence of ocular infection or inflammation within 30 days prior to Screening.
- Any ocular surgery.
- Ocular trauma requiring medical or pharmacological treatment within 1 year of Screening.
- Current presence of punctal plugs (permanent or temporary) or previous permanent punctal closure by cautery/diathermy.
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 |
|---|---|---|
| FID 119515Atopical ocular drops | Other | FID 119515A |
| Blink® Tearstopical ocular drops | Other | Blink |
Primary outcome
Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes
Time frame: Baseline, 60 minutes
Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used.
1 secondary outcome
Area Under Curve (AUC) of TBUT From 0 to 60 Minutes
Time frame: 0 to 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lisa Lindsey, PhD study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A study testing FID 119515A and Blink® Tears in people with Dry Eye, run by Alcon Research.
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 5 inclusion and 8 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 29 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 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?
Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes (time frame: Baseline, 60 minutes). 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 29 Jun 2018.