Safety and Efficacy of Optive in Contact Lens Wearers With Dry Eyes

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00469573

Enrollment

Registered

2007-05-04

Start date

2007-05-31

Completion date

2008-03-31

Last updated

2008-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Brief summary

The purpose of this study is to determine if Optive®eye drops are safe for people who wear contact lenses and have dry eyes. The second goal of the study is to determine if using Optive®eye drops can improve my dry eye scores on a standard dry eye test (called the OSDI).

Interventions

DRUG1. Optive

Optive 15ml- (in the eye) Instill one drop twice daily in each eye

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Men and women 18 and over * Self-reported use of daily-wear soft contact lenses that have been a proper fit for at least one month prior to the screening visit. * Complaint of dry eyes * OSDI score \> 23

Exclusion criteria

* Use of RGP or PMMA contact lenses * Poorly fitting contact lenses * Concurrent ocular conditions or pathology that could affect contact lens fit or patient's ability to complete study * Concurrent use of topical medications other than study medications * Use of systemic medications with ocular drying sequelae: * Antihistamines * Decongestants * Antispasmotics Antidepressants Change in contact lens care solutions within the prior 30 days

Design outcomes

Primary

Measure	Time frame
Safety	8 months

Secondary

Measure	Time frame
Efficacy	8 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026