NCT00758784

Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease

Completed Phase 2 Results posted Last updated 14 September 2020

What this trial tests

Phase 2 trial testing bromfenac ophthalmic solution 0.06% in Dry Eye Disease in 38 participants. Completed in 14 January 2009.

Timeline

13 August 2008

Primary endpoint
14 January 2009

14 January 2009

Quick facts

Lead sponsor	Bausch & Lomb Incorporated
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	38
Start date	13 August 2008
Primary completion	14 January 2009
Estimated completion	14 January 2009
Sites	1 location across United States

Drugs / interventions tested

• bromfenac ophthalmic solution 0.06% — full drug profile →

Conditions studied

• Dry Eye Disease — all drugs for Dry Eye Disease →

Sponsor

Bausch & Lomb Incorporated — full company profile →

Who can join

18 and older, any sex, with Dry Eye Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye Primary · 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 d

Group	Value	95% CI
Bromfenac Ophthalmic Solution 0.06%	-0.65	± 0.40

Percentage of Participants With at Least One Adverse Event Primary · 52 days

Group	Value	95% CI
Bromfenac Ophthalmic Solution 0.06%	9

Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye Secondary · Baseline, 42 days

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 conditio

Group	Value	95% CI
Bromfenac Ophthalmic Solution 0.06%	-0.84	± 0.75

Adverse events — posted to ClinicalTrials.gov

Time frame: 52 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Bromfenac Ophthalmic Solution 0.06%

Serious: 0/38 (0%)

Deaths: 0/38

Other adverse events (1 terms — click to expand)

Reaction	System	Bromfenac Ophthalmic Solut…
Nasopharyngitis	Infections and infestations	—

Data from ClinicalTrials.gov NCT00758784 adverse events section.

Sponsor's own description

The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.