Phase 4 Completed N=162 Randomized Treatment

Efficacy, Tolerability, and Comfort of 0.3% Hypromellose Eyedrops in Patients Undergoing LASIK Surgery

Dry Eye Disease

Source: ClinicalTrials.gov NCT00909324 ↗

Enrolled (actual)

162

Serious AEs

0.0%

Results posted

Mar 2011

Primary outcomePrimary: Ocular Comfort Level From Baseline to End of Study — 0.68; 0.84; 0.24; 0.31 Units on a scale

Summary

This study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to control (no pre-operative lubricant).

Outcome Measures

Outcome	Result	p-value
PRIMARY Ocular Comfort Level From Baseline to End of Study	0.68; 0.84; 0.24; 0.31; 0.08; 0.07	—
SECONDARY Tear Breakup Time From Baseline to End of Study	14.60; 12.47; 13.47; 10.84; 13.63; 12.70	—
SECONDARY Results of Schirmer's Test From Baseline to End of Study	19.64; 17.21; 17.68; 17.93; 21.70; 18.77	—

Eligibility Criteria

Inclusion Criteria

Age 21 - 35
Both sexes
Seeking LASIK surgery at the Refractive Surgery Centre
Meeting all established criteria for appropriateness for LASIK established by the treating center

Exclusion Criteria

Any corneal pathology including scars, prior herpes keratitis, prior corneal transplant
Any immuno-compromised state including cancer, HIV infection, Hepatitis B or C, or diabetes mellitus
Requirement for any eye-drops for any reason (eg, dry eye or conjunctivitis) within 3 months from time of enrollment
Anticipated refusal or inability to undergo planned post-operative visits or assessment
Failure to meet all established criteria for appropriateness for LASIK

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00909324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.