Dry Eye SyndromePhase 2NCT01163643

Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome

A Phase 2 study testing 0.3% BOL-303242-X ophthalmic suspension, 2% BOL-303242-X ophthalmic suspension and 1% BOL-303242-X ophthalmic suspension in people with Dry Eye Syndrome, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndrome
What is being tested?: 0.3% BOL-303242-X ophthalmic suspension, 2% BOL-303242-X ophthalmic suspension and 1% BOL-303242-X ophthalmic suspension
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 356 participants
Where: 1 siteUnited States
Study dates: Jul 2010to Jul 2011
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 who have a diagnosis of dry eye disease.
Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.
Subjects who are willing and able to refrain from using contact lenses during the study.

Who cannot join

Subjects with known hypersensitivity or contraindication to any component of the study medication.
Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter).
Subjects who are expected to require treatment with corticosteroids during the study.
Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit.
Subjects who have undergone any type of ocular surgery within three months prior to screening.
Lacrimal punctal occlusion (plugs or cautery) within 2 months of Screening Visit.
Subjects with a history or presence of chronic generalized systemic or ocular disease that the Investigator feels might increase the risk to the subject or confound the result of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bausch & Lomb
Rochester, New York, 14609

Other trials in United States

About this study

Official title: A Randomized, Double-Masked, Parallel-Group, Vehicle Controlled, Multicenter, Exploratory Study Assessing the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome

The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.

Conditions: Dry Eye Syndrome
Being tested: 0.3% BOL-303242-X ophthalmic suspension, 2% BOL-303242-X ophthalmic suspension, Placebo Comparator: Vehicle, 1% BOL-303242-X ophthalmic suspension, 2% BOL-303242-X ophthalmic suspension AM
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.

0.3% BOL-303242-X ophthalmic suspensionDrug
0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
2% BOL-303242-X ophthalmic suspensionDrug
2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
Placebo Comparator: VehicleDrug
Placebo Comparator: Vehicle BID for 12 weeks.
1% BOL-303242-X ophthalmic suspensionDrug
1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
2% BOL-303242-X ophthalmic suspension AMDrug
2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.
2% BOL-303242-X ophthalmic suspension PMDrug
Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.

Study groups in NCT01163643
Study group	Role	What they receive
0.3% BOL-303242-X ophthalmic suspension	Experimental	0.3% BOL-303242-X ophthalmic suspension Receives: Drug: 0.3% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension	Experimental	2% BOL-303242-X ophthalmic suspension Receives: Drug: 2% BOL-303242-X ophthalmic suspension
Vehicle	Placebo comparator	Vehicle twice daily (BID) Receives: Drug: Placebo Comparator: Vehicle
1% BOL-303242-X ophthalmic suspension	Experimental	1% BOL-303242-X ophthalmic suspension Receives: Drug: 1% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension in the morning	Experimental	2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) Receives: Drug: 2% BOL-303242-X ophthalmic suspension AM
2% BOL-303242-X ophthalmic suspension PM	Experimental	Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM. Receives: Drug: 2% BOL-303242-X ophthalmic suspension PM

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Corneal Staining Score
Total corneal staining score was calculated by adding the individual grades from 5 regions of the corneal surface (1: Central; 2: Superior; 3: Temporal; 4: Nasal; 5: Inferior). Grade 0 = none and Grade 3 = severe. The minimum total score possible was 0 and the maximum total score possible was 15. Higher scores indicated worse outcome.
Measured: 12 weeks
Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom
Each symptom (ocular discomfort, dryness, grittiness, and stinging) was assessed to the nearest millimeter on a 0 - 10 cm Visual Analog Scale (VAS) by the subject. The worst VAS dry eye symptom was utilized in the analysis. The minimum for the worst symptom was 0 and the maximum for the worst symptom was 10.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Jul 2011

First posted16 Jul 2010 (estimated)
Study startJul 2010
Primary completionJun 2011
Study completionJul 2011

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 SyndromeStudies 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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 356 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01163643
Sponsor's protocol ID: 637
Status last verified: Sep 2020
First submitted: 9 Jul 2010
Last updated: 25 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Masked, Parallel-Group, Vehicle Controlled, Multicenter, Exploratory Study Assessing the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome
ClinicalTrials.gov ID: NCT01163643
Acronym / sponsor ID: 637
Conditions: Dry Eye Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 356 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: Jul 2010
Primary completion: Jun 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 16 Jul 2010 (estimated)
Results: Posted 3 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 objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
0.3% BOL-303242-X ophthalmic suspension	Experimental	Drug: 0.3% BOL-303242-X ophthalmic suspension0.3% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension	Experimental	Drug: 2% BOL-303242-X ophthalmic suspension2% BOL-303242-X ophthalmic suspension
Vehicle	Placebo comparator	Drug: Placebo Comparator: VehicleVehicle twice daily (BID)
1% BOL-303242-X ophthalmic suspension	Experimental	Drug: 1% BOL-303242-X ophthalmic suspension1% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension in the morning	Experimental	Drug: 2% BOL-303242-X ophthalmic suspension AM2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM)
2% BOL-303242-X ophthalmic suspension PM	Experimental	Drug: 2% BOL-303242-X ophthalmic suspension PMVehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects who have a diagnosis of dry eye disease.
Intraocular pressure (IOP) ≤28 mmHg with no IOP lowering medications.
Subjects who are willing and able to refrain from using contact lenses during the study.

Key exclusion criteria (7 listed)

Subjects with known hypersensitivity or contraindication to any component of the study medication.
Subjects who are expected to require concurrent treatment with ophthalmic medications (prescription or over the counter).
Subjects who are expected to require treatment with corticosteroids during the study.
Subjects who have used topical or systemic isotretinoin, cyclosporine, or retinoid therapies within 30 days prior to the screening visit.
Subjects who have undergone any type of ocular surgery within three months prior to screening.

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
0.3% BOL-303242-X ophthalmic suspension0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.	Drug	0.3% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension2% BOL-303242-X ophthalmic suspension BID for 12 weeks.	Drug	2% BOL-303242-X ophthalmic suspension
Placebo Comparator: VehiclePlacebo Comparator: Vehicle BID for 12 weeks.	Drug	Vehicle
1% BOL-303242-X ophthalmic suspension1% BOL-303242-X ophthalmic suspension BID for 12 weeks.	Drug	1% BOL-303242-X ophthalmic suspension
2% BOL-303242-X ophthalmic suspension AM2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.	Drug	2% BOL-303242-X ophthalmic suspension in the morning
2% BOL-303242-X ophthalmic suspension PMVehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.	Drug	2% BOL-303242-X ophthalmic suspension PM

Primary outcome

Mean Corneal Staining Score
Time frame: 12 weeks
Total corneal staining score was calculated by adding the individual grades from 5 regions of the corneal surface (1: Central; 2: Superior; 3: Temporal; 4: Nasal; 5: Inferior). Grade 0 = none and Grade 3 = severe. The minimum total score possible was 0 and the maximum total score possible was 15. Higher scores indicated worse outcome.
Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom
Time frame: 12 weeks
Each symptom (ocular discomfort, dryness, grittiness, and stinging) was assessed to the nearest millimeter on a 0 - 10 cm Visual Analog Scale (VAS) by the subject. The worst VAS dry eye symptom was utilized in the analysis. The minimum for the worst symptom was 0 and the maximum for the worst symptom was 10.

Results and safety

Results posted to the registry on 3 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2% BOL-303242-X Ophthalmic Suspension	68	62
2% BOL-303242-X Ophthalmic Suspension in the Morning	37	35
2% BOL-303242-X Ophthalmic Suspension PM	35	33
1% BOL-303242-X Ophthalmic Suspension	74	69
0.3% BOL-303242-X Ophthalmic Suspension	69	61
Vehicle	73	66

Primary outcome: Mean Corneal Staining Score

Time frame: 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	2% BOL-303242-X Ophthalmic Suspension n = 64	2% BOL-303242-X Ophthalmic Suspension in the Morning n = 35	2% BOL-303242-X Ophthalmic Suspension PM n = 33	1% BOL-303242-X Ophthalmic Suspension n = 71	0.3% BOL-303242-X Ophthalmic Suspension n = 64	Vehicle n = 67
Value	4.0 (3.19)	3.9 (3.87)	3.9 (3.66)	4.4 (3.53)	4.1 (3.03)	3.7 (3.33)

Population analysed: Randomized participants with Week 12 results were included, with no imputation of missing data at Week 12.

Primary outcome: Mean Worst Visual Analog Scale(VAS) Dry Eye Symptom

Time frame: 12 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	2% BOL-303242-X Ophthalmic Suspension n = 64	2% BOL-303242-X Ophthalmic Suspension in the Morning n = 34	2% BOL-303242-X Ophthalmic Suspension PM n = 33	1% BOL-303242-X Ophthalmic Suspension n = 71	0.3% BOL-303242-X Ophthalmic Suspension n = 65	Vehicle n = 67
Value	2.256 (2.3172)	2.954 (2.4688)	2.290 (2.4885)	2.407 (2.6070)	2.535 (2.5565)	2.026 (2.1849)

Population analysed: Randomized participants with Week 12 results were included, with no imputation of missing data at Week 12.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2% BOL-303242-X Ophthalmic Suspension	0 of 67 (0%)	1 of 67 (1.5%)	Not reported
2% BOL-303242-X Ophthalmic Suspension in the Morning	0 of 37 (0%)	2 of 37 (5.4%)	Not reported
2% BOL-303242-X Ophthalmic Suspension PM	0 of 34 (0%)	1 of 34 (2.9%)	Not reported
1% BOL-303242-X Ophthalmic Suspension	0 of 73 (0%)	2 of 73 (2.7%)	Not reported
0.3% BOL-303242-X Ophthalmic Suspension	0 of 69 (0%)	3 of 69 (4.3%)	Not reported
Vehicle	0 of 71 (0%)	5 of 71 (7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 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.

Tuyen Ong, MD study director

Bausch & Lomb Incorporated

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 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 25 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. Some participants in this study may receive a placebo. 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 3 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 Corneal Staining Score (time frame: 12 weeks). 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?

On the ClinicalTrials.gov record for NCT01163643.

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 25 Sep 2020.