A Prospective, Randomized, Double-Masked, Single Center, Clinical Comparison of the Use of Systane Ultra in the Management of Dry Eyes in Bilateral Eyes

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00781092

Enrollment

Registered

2008-10-28

Start date

2008-10-31

Completion date

2009-03-31

Last updated

2012-09-20

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

Conditions

Dry Eye

Keywords

Dry Eyes, LASIK, Laser Vision Correction

Brief summary

The primary objective of this study is to compare two post operative drop regimens for the management of dry eye and control of healing using FDA-approved ophthalmic solutions.

Detailed description

This comparison will be made between bilateral eyes of the same patient following excimer laser ablation using the FDA-approved LADARVision 4000 Excimer Laser System or the WaveLight ALLEGRETTO WAVE™ Excimer Laser System. Post operative questionnaires regarding the use of the drops will be compared. Tear osmolarity and tear breakup time will be evaluated using Tear Lab and OQAS II.

Interventions

OTHERSystane Ultra

Ophthalmic Solution, 1 gtt, three times daily to both eyes for 1 month post operative

OTHERBausch and Lomb Sensitive Eyes

Ophthalmic Solution, 1 gtt, three times a day in both eyes for 1 month after LASIK

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Subjects must be a suitable candidate for FDA Approved LASIK. * Subjects must have a stable refraction as documented by previous clinical records. * Subjects who wear soft contact lenses must discontinue wear at least 3 days prior to preoperative exam or surgery. * Subjects who wear gas permeable contact lenses must discontinue wear at least 3 weeks prior to preoperative exam or surgery. * Subjects must be at least 18 years of age. * Subjects must be willing and able to return for scheduled follow up examinations each day after surgery at the specified time. * Subjects must sign and be given a copy of the written Informed Consent form.

Exclusion criteria

* Subjects for whom either eyes do not meet all inclusion criteria and either eye meets any

Design outcomes

Primary

Measure	Time frame
Tear osmolarity	2 week, 1 month

Secondary

Measure	Time frame
Tear Break Up Time	2 week, 1 month post op

Outcome results

None listed

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