Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Change from baseline in Ocular Surface Disease Index (OSDI) score	12 weeks	The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
Secondary	Change from baseline in Ocular Surface Disease Index (OSDI) score	12 weeks	The OSDI© is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
Secondary	Proportion of subjects achieving ≥10-point improvement in OSDI score	12 weeks	Proportion of subjects achieving an improvement of 10 points or more in OSDI score from baseline following bilateral LASIK.
Secondary	Proportion of subjects achieving OSDI score <13	12 weeks	Proportion of subjects with an OSDI score below 13 (normal range) at the 12-week postoperative visit.
Secondary	Change from baseline in tear break-up time (TBUT)	12 weeks
Secondary	Change from baseline in corneal fluorescein staining (National Eye Institute Corneal Staining Scale)	12 weeks
Secondary	Uncorrected distance visual acuity (UDVA)	12 weeks
Secondary	Corrected distance visual acuity (CDVA)	12 weeks
Secondary	Manifest refraction	12 weeks
Secondary	Artificial tear usage and time to discontinuation of routine artificial tears	12 weeks	Artificial tear usage, time to discontinuation of routine artificial tears, and requirement for rescue dry eye therapy through the 12-week postoperative visit.
Secondary	Requirement for rescue dry eye therapy	12 weeks	Incidence and documentation (indication, timing, treatment administered) of rescue dry eye therapy through the 12-week postoperative visit.
Other	PROWL-SS Questionnaire	12 weeks	PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question. Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome for the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items).
Other	Change from baseline in iTrace Corneal Performance Index (CPI)	12 weeks	Objective optical quality measure assessed at baseline and12-week postoperative visit.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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