Dry Eye DiseasePhase 2NCT00758784
Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
A Phase 2 study testing bromfenac ophthalmic solution 0.06% in people with Dry Eye Disease, run by Bausch & Lomb Incorporated at 1 site in United States.
Trial summary
The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- bromfenac ophthalmic solution 0.06%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2008to 14 Jan 2009
- Phase
- Phase 2
- 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
- Subjects 18 years of age or older
Who cannot join
- No active ocular conditions of disease
Trial locations and contacts
1 site in 1 country.
United States1 site
ISTA Pharmaceuticals, Inc.
Irvine, California, 92618
About this study
The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.
- Conditions
- Dry Eye Disease
- Being tested
- bromfenac ophthalmic solution 0.06%
- 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.
bromfenac ophthalmic solution 0.06%Drug
bromfenac ophthalmic solution 0.06% bilaterally twice a day
| Study group | Role | What they receive |
|---|---|---|
| bromfenac ophthalmic solution 0.06% | Experimental | bromfenac ophthalmic solution 0.06% bilaterally twice a day Receives: Drug: bromfenac ophthalmic solution 0.06% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye
Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for total scoring ranged from 0 to 18 units summed across all 6 conjunctival regions, with a higher score suggesting a more dry eye condition. An average of the 6 areas was computed, providing an average score of 0-3 units. The study eye utilized for analysis was selected by pre-specified criteria.
Measured: Baseline, Day 42
Percentage of Participants With at Least One Adverse Event
Measured: 52 days
Secondary outcomes (1)
Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye
Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for worst region of Lissamine Green staining ranged from 0 to 3 units, with a higher score suggesting a more dry eye condition.The worst region of lissamine green staining was determined at the baseline visit. The study eye utilized for analysis was selected based on pre-specified criteria.
Measured: Baseline, 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study start13 Aug 2008
- Primary completion14 Jan 2009
- Study completion14 Jan 2009
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 Eye DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim McNamara, PharmD, Study director, ISTA Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00758784
- Sponsor's protocol ID
- CL-S&E-0417082-P
- Status last verified
- Aug 2020
- First submitted
- 19 Sep 2008
- Last updated
- 14 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
- ClinicalTrials.gov ID
- NCT00758784
- Acronym / sponsor ID
- CL-S&E-0417082-P
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2008
- Primary completion
- 14 Jan 2009 (actual)
- Study completion
- 14 Jan 2009 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 14 Sep 2020
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 investigate the safety and efficacy of an ophthalmic solution in dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bromfenac ophthalmic solution 0.06% | Experimental | Drug: bromfenac ophthalmic solution 0.06%bromfenac ophthalmic solution 0.06% bilaterally twice a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects 18 years of age or older
Key exclusion criteria (1 listed)
- No active ocular conditions of disease
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 |
|---|---|---|
| bromfenac ophthalmic solution 0.06%bromfenac ophthalmic solution 0.06% bilaterally twice a day | Drug | bromfenac ophthalmic solution 0.06% |
Primary outcome
Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye
Time frame: Baseline, Day 42
Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for total scoring ranged from 0 to 18 units summed across all 6 conjunctival regions, with a higher score suggesting a more dry eye condition. An average of the 6 areas was computed, providing an average score of 0-3 units. The study eye utilized for analysis was selected by pre-specified criteria.
Percentage of Participants With at Least One Adverse Event
Time frame: 52 days
1 secondary outcome
Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye
Time frame: Baseline, 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- 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.
Tim McNamara, PharmD study director
ISTA Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bromfenac ophthalmic solution 0.06% in people with Dry Eye Disease, run by Bausch & Lomb Incorporated 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 1 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 14 Sep 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 14 Sep 2020). 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 Average Lissamine Green Staining in the Study Eye (time frame: Baseline, Day 42). The study lists 2 primary outcomes in all. 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 14 Sep 2020.