Trial Outcomes & Findings for An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease (NCT NCT01711424)

Last Updated: 2014-03-17

Results Overview

Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).

Recruitment status

COMPLETED

Target enrollment

1209 participants

Primary outcome timeframe

Week 4

Results posted on

2014-03-17

Participant Flow

Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice. There was no investigational drug administered in this study.

Participant milestones

Participant milestones
Measure	OPTIVE PLUS® Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
Overall Study STARTED	1209
Overall Study COMPLETED	1209
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OPTIVE PLUS® n=1209 Participants Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
Age, Customized <18 Years	3 Participants 15.89 • n=5 Participants
Age, Customized 18 to 30 Years	51 Participants n=5 Participants
Age, Customized 31 to 40 Years	94 Participants n=5 Participants
Age, Customized 41 to 50 Years	196 Participants n=5 Participants
Age, Customized 51 to 60 Years	230 Participants n=5 Participants
Age, Customized 61 to 70 Years	261 Participants n=5 Participants
Age, Customized 71 to 80 Years	269 Participants n=5 Participants
Age, Customized 81 to 90 Years	84 Participants n=5 Participants
Age, Customized >= 91 Years	5 Participants n=5 Participants
Age, Customized Missing data	16 Participants n=5 Participants
Sex/Gender, Customized Male	398 Participants n=5 Participants
Sex/Gender, Customized Female	805 Participants n=5 Participants
Sex/Gender, Customized Missing Data	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 4

Population: All participants with data available for this outcome measure.

Patients rated their satisfaction with OPTIVE PLUS® as treatment for dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).

Outcome measures

Outcome measures
Measure	OPTIVE PLUS® n=1191 Participants Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS® Very satisfied	356 Participants
Number of Participants Very Satisfied or Satisfied With OPTIVE PLUS® Satisfied	746 Participants

SECONDARY outcome

Timeframe: Week 4

Population: All participants with data available for this outcome measure.

The physician rated their satisfaction with OPTIVE PLUS® for the treatment of their patient's dry eye signs and symptoms using a 4-point scale (Very satisfied, Satisfied, Dissatisfied or Very dissatisfied).

Outcome measures

Outcome measures
Measure	OPTIVE PLUS® n=1176 Participants Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS® Very satisfied	367 Participants
Number of Participants Where Physician Was Very Satisfied or Satisfied With OPTIVE PLUS® Satisfied	734 Participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: All participants with complete data available for this outcome measure at Baseline and Week 4.

TBUT is the time in seconds required for dry spots to appear on the corneal surface after blinking. The longer it takes, the more stable the tear film.

Outcome measures

Outcome measures
Measure	OPTIVE PLUS® n=475 Participants Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
Tear Break Up Time (TBUT) Baseline	7.0 Seconds Interval 2.0 to 23.0
Tear Break Up Time (TBUT) Week 4	10.0 Seconds Interval 2.0 to 23.0

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: All participants with complete data available for this outcome measure at Baseline and Week 4.

The Schirmer Test measures the rate of the secretion of tears produced by the eye over 5 minutes (min). The results indicate the presence of dry eye (Normal = greater than or equal to 10 millimeters (mm) of tears, Dry Eye = less than 10 mm of tears). The smaller the number, the more severe the dry eye.

Outcome measures

Outcome measures
Measure	OPTIVE PLUS® n=307 Participants Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
Schirmer Score Baseline	8.0 mm/5 min Interval 1.0 to 30.0
Schirmer Score Week 4	10.0 mm/5 min Interval 1.0 to 30.0

Adverse Events

OPTIVE PLUS®

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	OPTIVE PLUS® n=1209 participants at risk Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
Eye disorders Cataract operation	0.17% 2/1209

Other adverse events

Adverse event data not reported

Additional Information

Vice President Medical Affairs,

Allergan, Inc

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER